Medicine recalls

• Sept. 30, 2026Olanzapine Tablets… Class IIINewFailed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
• Sept. 30, 2026AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%… and 8 more products Class IINewLack of Assurance of Sterility
• Sept. 30, 2026Menow Sunscreen Pressed Powder Spf35 Pa+++… Class IINewcGMP Deviations
• Sept. 23, 2026Nystatin Cream… Not Yet ClassifiedNewFailed Stability Specifications
• Sept. 23, 2026Thyroid Tablets… Class INewSuperpotent Drug
• Sept. 23, 2026Dopamine HCl Inj… Class IINewLack of Assurance of Sterility
• Sept. 23, 2026Chlorthalidone Tablets… Class IINewFailed Dissolution Specifications
• Sept. 23, 2026Lidocaine Ointment USP… Class IINewFailed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at…
• Sept. 23, 2026Fluphenazine HCl Elixir… and 5 more products Class IINewFailed Stability Specifications
• Sept. 21, 2026Par Pharmaceutical Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for… NewPresence of particulate matter identified as cellulose or stopper material
• Sept. 21, 2026ICU Medical LLC 0.9% Sodium Chloride Injection, USP, 100 mL NewProduct mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
• Sept. 16, 20260.9% Sodium Chloride Injection… Class INewPresence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
• Sept. 16, 2026Epinephrine Injection… Class INewPresence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and…
• Sept. 16, 2026fentaNYL Citrate… Class IINewLabeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and…
• Sept. 16, 2026Dextrose Injection… Class INewPresence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
• Sept. 16, 2026Fluphenazine Hydrochloride Tablets… Class IIINewFailed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability.…
• Sept. 16, 2026Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution… Class IIINewSubpotent Drug
• Sept. 13, 2026Centric Compounding Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose… NewElevated Endotoxin level
• Sept. 9, 2026Glutathione 200 mg/mL… Class IMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
• Sept. 9, 20260.9% Sodium Chloride Injection USP 500 mL… Class IPresence of particulate matter: Particulates identified as fiberglass
• Sept. 9, 2026Prasugrel HCI… Class IIFailed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
• Sept. 9, 2026Buprenorphine Sublingual Tablets (C-III)… Class IIILabeling: Label Mix-up
• Sept. 9, 2026Prasugrel Tablets… Class IIFailed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
• Sept. 9, 2026Revcovi (elapegademase-lvlr) Injection… Class IIIFailed Stability Specifications: Out of specification stability result for the protein concentration profile.
• Sept. 9, 20262% Chlorhexidine Gluconate* Cloth… Class IICross Contamination with Other Products
• Sept. 9, 2026traZODone Hydrochloride Tablets… Class IIPresence of Foreign Tablets/Capsules
• Sept. 9, 2026Trokendi XR… Class IIIFailed dissolution specifications.
• Sept. 9, 2026Carton label: Mycophenolate Mofetil for injection… Class IIFailed Dissolution Specifications
• Sept. 9, 2026Broadway Joe's Pain Cream… and 1 more product Class IICGMP Deviations: Potential contamination of raw material
• Sept. 9, 2026The One SPF 50 Invisible Sunscreen Gel… and 3 more products Class IISubpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
• Sept. 9, 2026Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg… Class IIIPresence of Foreign Tablets/Capsules
• Sept. 9, 2026Vancomycin Injection… and 16 more products Class IICGMP Deviations
• Sept. 3, 2026B. Braun 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Presence of particulate matter identified as iron oxide
• Sept. 2, 2026Lactated Ringer's Injection USP… Class IPresence of Particulate matter.
• Sept. 2, 2026Ramipril Capsules USP… Class IIFailed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
• Sept. 2, 2026Tyenne (tocilizumab-aazg) Injection… Class IPresence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
• Sept. 2, 2026Paxil CR… Class IIFailed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
• Sept. 2, 2026Acthar Gel (repository corticotropin injection)… Class IIPresence of particulate matter: glass and stopper piece
• Sept. 2, 2026Zicam… Class IICGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
• Sept. 2, 2026Clobetasol Propionate Cream USP… Class IIFailed content uniformity specifications.
• Sept. 2, 2026Levothyroxine Sodium Tablets… and 11 more products Class IISubpotent Drug
• Aug. 31, 2026Lipofit Extreme 2.0 Fat Burner Dietary Supplement Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
• Aug. 26, 2026Nitroglycerin injection… and 11 more products Class IPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
• Aug. 26, 2026Morphine Sulfate Injection… Class ILabeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
• Aug. 26, 2026Acamprosate Calcium… Class IIFailed Dissolution Specifications
• Aug. 26, 2026Carbamazepine Tablets… Class IICGMP deviations: tablets with black specks.
• Aug. 26, 2026Carbamazepine Tablets… Class IICGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
• Aug. 26, 2026Libtayo (cemiplimab-rwlc) Injection… Class IILack of Assurance of Sterility
• Aug. 26, 2026PEMRYDI RTU (pemetrexed injection)… and 1 more product Class IIDiscolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
• Aug. 26, 2026Baxter 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container Potential presence of particulate matter identified as fiberglass in the solution.
• Aug. 25, 2026Baxter Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container Potential presence of particulate matter identified as fiberglass in the solution
• Aug. 25, 2026Baxter 70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container Potential presence of particulate matter identified as stainless steel particles in the solution.
• Aug. 24, 2026Vitruvias Therapeutics Thyroid Tablets, USP 30 mg Potential for the Product to be Superpotent
• Aug. 20, 2026Optimal Balance Pharmacy Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial Elevated Endotoxin level
• Aug. 19, 2026Cefazolin in Dextrose… Class IPresence of Particulate Matter
• Aug. 19, 2026Optiray Imaging Bulk Package-350… Class IPresence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
• Aug. 19, 2026Glutathione (MDV)… Class IMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
• Aug. 19, 2026Kian Pee Wan Capsules… Class IMarketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
• Aug. 19, 2026Clindamycin Palmitate Hydrochloride For Oral Solution… Class IIPresence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
• Aug. 19, 2026CLEAR EYES Maximum Itchy Eye Relief… Class IILack of assurance of sterility. The recall is due to potential contamination
• Aug. 19, 2026Sildenafil Citrate USP… and 4 more products Class IICGMP Deviations:Noted during FDA inspection
• Aug. 19, 2026SEMAGLUTIDE 12.5MG (2.5MG/mL)… and 10 more products Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
• Aug. 19, 2026Diovan (valsartan) 160 mg… Class IIFailed Dissolution Specifications
• Aug. 19, 2026B. Braun Excel® Lactated Ringers Injection, 1000mL Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and…
• Aug. 12, 2026Mirabegron Extended-Release Tablets… Class IICGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
• Aug. 12, 2026Cyclophosphamide for Injection… and 1 more product Class IPresence of Particulate Matter; identified as stainless steel
• Aug. 12, 2026Total Parental Nutrition… Class IIIIncorrect Product Formulation
• Aug. 12, 2026Dicyclomine Hydrochloride Capsules… Class IIshortfill; reports of empty capsules.
• Aug. 11, 2026Fresenius Kabi Tyenne Injection 400 mg/20 mL vial Due to Presence of Glass Particles
• Aug. 5, 2026Dabigatran Etexilate Capsules… and 2 more products Class IIIFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
• Aug. 5, 2026Mycophenolate Mofetil for Injection USP… Class IIPresence of precipitate
• Aug. 5, 2026Azelaic Acid Gel… Class IICGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
• Aug. 5, 2026Dorzolamide HCl and Timolol Maleate Ophthalmic Solution… Class IIDefective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
• Aug. 5, 2026VMC Compounded Glutathione 200 mg/mL Multi-Dose Vials Elevated Endotoxin level
• Aug. 5, 2026Fresenius Kabi Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL Due to a label mix-up
• Aug. 4, 2026OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml) Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
• Aug. 3, 2026American Regent, Inc. Animal Health Adequan Canine Injection and Adequan i.m Injection for horses Visible glass fiber material in the product
• July 29, 2026Trokendi XR… Class IIIFailed Dissolution Specifications
• July 29, 2026Divalproex Sodium Delayed-Release Tablets… Class IIPresence of Foreign Tablets/Capsules
• July 29, 2026Glycopyrrolate Oral Solution… Class IIFailed Impurities/Degradation Specifications
• July 29, 2026Dabigatran etexilate Capsules… and 1 more product Class IIIFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
• July 29, 2026Cetirizine Hydrochloride Tablets USP 5 mg… Class ICross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
• July 29, 2026Glycopyrrolate Injection… and 4 more products Class IIPresence of Particulate Matter: Hair was found in product
• July 29, 2026Rising… Class IIPresence of Precipitate: medication was crystallizing and particles floating in the bottle
• July 29, 2026Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%… and 7 more products Class IILack of Assurance of Sterility
• July 29, 2026Lidolog Kit… Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
• July 29, 2026Amlodipine and Olmesartan Medoxomil Tablets… Class IIFailed Dissolution Specifications; Olmesartan Medoxomil content below specifications
• July 29, 2026Levothyroxine Sodium Tablets… and 11 more products Class IISubpotent Drug
• July 27, 2026American Regent, Inc. Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Products were found to contain particulate matter
• July 24, 2026Long Grove Pharmaceuticals Cyclophosphamide for Injection Presence of particulate matter identified as steel
• July 24, 2026Baxter Cefazolin in Dextrose Injection Particulate matter (cardboard) found in the solution.
• July 22, 2026BD ChloraPrep Clear… Class IILack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
• July 22, 2026CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL)… Class IILack of Assurance of Sterility
• July 22, 2026CVS Health… and 10 more products Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
• July 22, 2026Nystatin Cream USP… Class IISubpotent Drug: Low out of specification assay results performed during long-term stability testing.
• July 20, 2026Rising Pharma Holdings Inc. Cetirizine Hydrochloride Tablets USP 5 mg Potential cross contamination with Ranitidine
• July 15, 2026Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9)… Class IIcGMP deviations
• July 15, 2026Pemetrexed for Injection 100mg/Vial… and 3 more products Class IILack of Sterility Assurance
• July 15, 2026Gasco Isopropyl Alcohol 70%… and 5 more products Class IISubpotent drug
• July 15, 2026Methohexital Sodium… Class IIFailed Impurities/Degradation Specifications
• July 15, 2026Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries… Class IIFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
• July 15, 2026Methohexital Sodium for Injection… Class IIFailed Impurities/Degradation Specifications
• July 8, 2026Glucagon Emergency Kit for Low Blood Sugar… Class IICGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
• July 8, 2026Gemcitabine Injection… Class IITemperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
• July 8, 2026Revitaderm Wound Care Gel… and 7 more products Class IMicrobial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
• July 8, 2026Cinacalcet Hydrochloride Tablets… and 2 more products Class IIcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
• July 8, 2026Dextroamphetamine Saccharate… Class IILabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
• July 8, 2026Accucaine… and 1 more product Class IILack of Assurance of Sterility
• July 8, 2026Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)… Class IICGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
• July 8, 2026Levothyroxine Sodium Tablets… Class IISubpotent Drug
• July 8, 2026prednisoLONE Acetate Ophthalmic Suspension… Class IIPresence of Foreign Substance
• July 8, 2026Fexofenadine Hydrochloride Tablets… Class IIIFailed Impurities/Degradation Specifications
• July 8, 2026Imuldosa… Class IILack of assurance of Sterility:
• July 8, 2026BD ChloraPrep Hi-Lite Orange… and 9 more products Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
• July 1, 2026Perampanel CIII Tablets… Class IILabeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
• July 1, 2026Povi-One… Class IIsub potency
• July 1, 2026Lacosamide Tablets… Class IIPresence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
• July 1, 2026BD ChloraPrep Clear… and 3 more products Class ILack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
• July 1, 2026PReye Vitamin See Antioxidant Preservative Free Eye Drops… Class IILack of Assurance of Sterility
• July 1, 2026hydrOXYzine Hydrochloride Oral Solution… Class IIIPresence of foreign substance
• July 1, 2026Total Parental Nutrition… Class IIIncorrect product formulation: bag did not contain copper and famotidine per label.
• July 1, 2026Duloxetine D/R… Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
• July 1, 2026Corlanor (ivabradine) tablets… and 4 more products Class IIPresence of Foreign Substance.
• July 1, 2026Fenofibrate Capsules… Class IICGMP Deviations
• July 1, 2026Carton Label: MAJOR… Class IISubpotent Drug
• June 24, 2026Lucky Super Soft… and 13 more products Class IICGMP Deviations; deficiencies observed during FDA inspection
• June 24, 2026Chlorthalidone Tablets… Class IIFailed Dissolution Specifications
• June 24, 2026Focalin XR (dexmethylphenidate HCl) 5 mg… Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
• June 24, 2026Pearson Quality Topical Anesthetic Gel (20% Benzocaine)… and 6 more products Class IIDefective container:may contain bottles with incomplete seals
• June 24, 2026Buprenorphine HCl… Class IICrystallization; identified as Buprenorphine free base
• June 24, 2026Aripiprazole Tablets USP… Class IIProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
• June 24, 2026Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride… Class IISubpotent Drug
• June 24, 2026VistaPharm… and 3 more products Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
• June 24, 2026Alyacen 7/7/7… Class IIFailed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
• June 17, 2026BEEKEEPER'S NATURALS Saline Nasal Spray… Class IMicrobial Contamination of Non-Sterile Products
• June 17, 2026Budesonide Inhalation Suspension… Class IIPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles…
• June 17, 2026Minocycline Hydrochloride Extended-Release Tablets… Class IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
• June 17, 2026Gas-X Extra Strength… Class IChemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
• June 17, 2026GSMS Incorporated… Class IIFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…
• June 17, 2026Zep… Class IIMicrobial contamination of sterile products
• June 17, 2026Primidone Tablets… Class IIICross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
• June 17, 2026Duloxetine Delayed-Release Capsules… and 1 more product Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
• June 17, 2026Epinephrine Injection… Class IIIFailed Impurities/Degradations Specifications
• June 17, 2026DOXOrubin Hydrochloride Liposome injection… Class IPresence of Particulate matter: Particulate matter identified as glass.
• June 12, 2026Beekeeper’s Naturals Saline Nasal Spray Above acceptable microbiological limits for yeast and may contain Aspergillus spp.
• June 10, 2026Xyvona (levorphanol tartrate tablets)… and 1 more product Class IILabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary…
• June 10, 2026Niacin Extended-release Tablets… Class IIFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
• June 10, 2026KIRKLAND Signature… and 22 more products Class IIPresence of foreign substance: small metallic particles in chewable tablets.
• June 10, 2026Amlodipine and Olmesartan Medoxomil Tablets… Class IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specifications
• June 10, 2026Duloxetine DR Capsules… Class IICGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
• June 10, 2026Lidocaine HCl Injection USP… Class IILack of Assurance of Sterility
• June 10, 2026Lidocaine HCl Injection… Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
• June 8, 2026BD ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
• June 4, 2026Gas-X Gass-X Extra Strength Softgels 120 and 72ct Potential chemical contamination
• June 3, 2026Pred Mild… Class IIIFailed Stability Specifications
• June 3, 2026Nicotine Transdermal System Patch… Class IIIFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
• May 27, 2026MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)… Class IMicrobial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
• May 27, 2026Vitamin B-Complex… Class IIPresence of a Foreign Substance; black particles observed in liquid
• May 27, 2026fentaNYL Citrate… Class IISubpotent Drug
• May 27, 2026cimzia (certolizumab pegol)… Class IILack of Assurance of Sterility
• May 27, 2026Erythromycin Tablets… and 1 more product Class IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
• May 27, 2026Estradiol Gel… Class IIDefective Container; packets were found to be either empty or partially full.
• May 27, 2026Gas-X… Class IILabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
• May 27, 2026Liraglutide Injection… Class IIPresence of particulate matter: a white thread-like structure in the cartridge
• May 27, 2026Busulfan Injection… Class IIIFailed Impurities/Degradation Specifications
• May 27, 2026Atomoxetine Capsules HCL… Class IILabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
• May 27, 2026Primidone Tablets… and 1 more product Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
• May 27, 2026Primidone Tablets… and 1 more product Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
• May 27, 2026Primidone Tablets USP… Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
• May 20, 2026Ascend Laboratories… Class IIFailed Dissolution Specifications
• May 20, 2026Buprenorphine Hydrochloride… Class IICrystallization; identified as Buprenorphine free base
• May 20, 2026Oasis Tears PF… Class IILack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent…
• May 13, 2026Lactated Ringer's Injection USP… Class IPresence of Particulate Matter.
• May 13, 2026TPN bag (patient specific)… Class IIIncorrect Product Formulation: product did not contain insulin as listed in the label.
• May 13, 2026Naproxen Oral Suspension… Class IIChemical contamination; presence of lead and lithium above specification
• May 13, 2026Duloxetine Delayed-Release Capsules USP… Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
• May 13, 2026Enalapril Maleate Tablets… Class IIFailed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
• May 13, 2026Octreotide Acetate for Injectable Suspension… Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
• May 13, 2026BD PurPrep… and 1 more product Class IILack of assurance of Sterility: potential product contamination
• May 13, 2026Duloxetine Delayed-Release Capsules… and 2 more products Class IICGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
• May 13, 2026Delflex… and 1 more product Class IILack of Assurance of Sterility: Potential leaks from perforations in bags.
• May 13, 2026busPIRone Hydrochloride Tablets… Class IIISubpotent drug
• May 13, 2026Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Presence of glass particles
• May 12, 2026Mg217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube Contaminated with Staphylococcus aureus.
• May 6, 2026Alendronate Sodium Oral Solution… Class IIThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
• May 6, 2026Lidocaine Wound Gel (Benzalkonium Chloride… Class IIIFailed PH Specifications
• May 6, 2026Phenylephrine Hydrochloride Injectable Solution… and 6 more products Class IIcGMP deviations.
• May 6, 2026iVIZIA… and 1 more product Class IILack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
• May 6, 2026Optase Dry Eye Intense Drops (Glycerin 0.2%)… Class IILack of Assurance of Sterility
• May 6, 2026Levocarnitine Injection… Class IIILabeling: Missing Label
• May 6, 2026Systane… and 1 more product Class IILack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
• April 29, 2026Claravis (isotretinoin capsule… Class IIFailed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
• April 29, 2026Sterile Water for Injection USP… and 3 more products Class IILack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
• April 29, 2026Omega-3-Acid… Class IIFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
• April 29, 2026Premier… Class IIILabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
• April 29, 2026Freshkote Lubricant Eyedrops… Class IILack of Assurance of Sterility
• April 29, 2026Furosemide Tablets… Class IICGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
• April 29, 2026Pantoprazole Sodium… Class IIDiscoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
• April 28, 2026B. Braun Lactated Ringer’s Injection, E7500, 1L Products were found to contain particulate matter in solution
• April 22, 2026Lidocaine HCl injection… and 3 more products Class IILack of Assurance of Sterility
• April 22, 2026Desmopressin Nasal Spray… Class IIDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
• April 22, 2026Magnesium Chloride… Class IIISubpotent drug
• April 22, 2026Blemish Spot Treatment (Salicylic Acid) 1%… Class IIFailed Stability Specifications
• April 22, 2026Memantine Hydrochloride Extended-Release… Class IIFailed Dissolution Specifications
• April 22, 2026EPINEPHRINE Injection… Class IILack of Assurance of Sterility
• April 22, 2026Remedy Gel… and 2 more products Class IIISubpotent Drug
• April 22, 2026Albuterol Sulfate Inhalation Solution… Class IILabelling: Illegible label
• April 22, 2026Fluocinonide… and 2 more products Class IIFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
• April 22, 2026Semaglutide-Glycine-Cyanocobalamin Injectable… Class IILack of Assurance of Sterility
• April 22, 2026exchange select… and 14 more products Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
• April 22, 2026FHF Farmhouse Fresh… and 3 more products Class IIChemical contamination: Presence of benzene
• April 22, 2026Cinacalcet Hydrochloride Tablets… and 2 more products Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
• April 15, 2026Clonidine Transdermal System… and 2 more products Class IICGMP Deviations: use of an unapproved raw material
• April 15, 2026GE Healthcare Omnipaque (iohexol) Injection… and 1 more product Class IIPresence of particulate matter
• April 15, 2026Isotretinoin Capsules… and 1 more product Class IISuperpotent and Subpotent
• April 15, 2026Xanax XR… Class IIFailed Dissolution Specifications
• April 15, 2026Artificial Tears Lubricant Eye Drops (glycerin 0.2%… Class IILack of Assurance of Sterility
• April 15, 2026norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride… and 4 more products Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
• April 15, 20260.45% Sodium Chloride Injection… and 13 more products Class IILack of Assurance of Sterility
• April 15, 2026Lanreotide Injection… and 1 more product Class IILack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
• April 8, 2026Magnesium Sulfate in Water for Injection… Class IProduct mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
• April 8, 2026Prazosin Hydrochloride Capsules… and 2 more products Class IIcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
• April 8, 2026Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%… and 7 more products Class IILack of Assurance of Sterility
• April 8, 2026traMADol Hydrochloride Tablets… Class IIFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
• April 8, 2026Revitaderm, Tridergel Antiseptic wound care gel bottles and tubes Products were found to contain Lysinibacillus fusiformis, an environmental organism
• April 1, 2026Meclizine Hydrochloride Tablets… Class IIFailed tablet specifications.
• April 1, 2026Octreotide Acetate for Injectable Suspension… and 2 more products Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
• April 1, 2026Levothyroxine Sodium Tablets USP 150 mcg… Class IISubpotent Drug
• April 1, 2026CUROSURF (poractant alfa)… Class IILack of Assurance of Sterility
• April 1, 2026Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic… Class IIIFailed Tablet/Capsule Specifications
• April 1, 2026Kian Pee Wan Dietary supplement capsules marketed for treatment for gaining weight and stimulating appetite. Device & Drug Safety/Unapproved Drug
• March 25, 2026Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply… Class INon-Sterility: microbial contamination identified as Paenibacillus phoenicis
• March 25, 2026Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*… Class IILack of Assurance of Sterility
• March 25, 2026Dexamethasone Sodium Phosphate Injection… Class IIFailed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were…
• March 25, 2026Pitavastatin Tablets… Class IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
• March 25, 2026Children's Ibuprofen Oral Suspension… Class IIPresence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
• March 24, 2026Amneal Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL.
• March 20, 2026Webcol Large Alcohol Prep Pads (70% isopropyl alcohol) Microbial Contamination
• March 18, 2026Icosapent Ethyl Capsules… Class IIFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
• March 11, 2026Amnesteem (Isotretinoin) Capsules… Class IIFailed Dissolution Specifications
• March 11, 2026MR. 7 SUPER 700000 capsules… Class IMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
• March 11, 2026Mojo Max Fusion XXX… Class IMarketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
• March 11, 2026Semaglutide Inj… and 3 more products Class IILack of Assurance of Sterility
• March 11, 2026Sodium Iodide (I-131) Solution… Class IIPresence of Particulate Matter: Due to production issues
• March 11, 2026SILINTAN 25/pills… Class IMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
• March 11, 2026Five-Star… and 2 more products Class IIStability Data Does Not Support Expiry Date.
• March 11, 2026Product label: Temozolomide Capsules… Class IIFailed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
• March 11, 2026Midodrine Hydrochloride Tablets… Class IIDefective container; inadequately sealed blister packaging.
• March 11, 2026Nilotinib Capsules… and 1 more product Class IIIFailed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual…
• March 11, 2026Semaglutide… and 1 more product Class IICGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before…
• March 11, 2026First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride… and 20 more products Class IICGMP Deviations
• March 11, 2026Metoprolol Succinate Extended-Release Tablets… and 3 more products Class IIFailed Dissolution Specifications
• March 4, 2026Vista Tears Polyethylene Glycol 400 0.4% w/v… and 6 more products Class IILack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
• March 4, 2026Agebox iKids-Growth (Day Formula) capsules… and 1 more product Class IIMarketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
• March 4, 2026Eptifibatide Injection… Class IIILabeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The…
• March 4, 2026Amantadine HCl… Class IIFailed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
• March 4, 2026Adbry… Class IILack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
• Feb. 18, 2026Udenyca… Class ITemperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment…
• Feb. 18, 2026Cetrorelix Acetate for Injection (Kit)… Class IIDefective Delivery System: Missing or duplicated needles within the injection kit
• Feb. 18, 2026Oxycodone Hydrochloride Tablets… Class IIDefective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
• Feb. 18, 2026acyclovir sodium… and 4 more products Class IILack of Assurance of Sterility
• Feb. 18, 2026Estradiol… and 24 more products Class IIPresence of Foreign substance - potential presence of metal particulate matter
• Feb. 18, 2026Doxazosin Tablets… Class IIITablets/Capsules Imprinted with Wrong ID
• Feb. 18, 2026Pro Numb Tattoo Numbing Spray… and 1 more product Class IIcGMP deviations
• Feb. 11, 2026Diclofenac Sodium… Class IIFailed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
• Feb. 11, 2026Rheumacare capsules… Class ICGMP Deviations: product found to contain lead.
• Feb. 11, 2026Trazodone Hydrochloride… Class IIPresence of Foreign Tablets/Capsules
• Feb. 11, 2026Green Lumber Natural Fuel For Men capsule… Class IMarketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
• Feb. 11, 2026Bisoprolol Fumarate and Hydrochlorothiazide tablets… Class IIcGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
• Feb. 4, 2026Glycopyrrolate Oral Solution… Class IIIFailed Impurities/Degradation Specifications
• Feb. 4, 2026methylprednisolone tablets… Class IILabeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
• Feb. 4, 2026INON ACE Antacid tablets (magnesium aluminosilicate… Class IIFailed Disintegration Specifications: above the time expected.
• Feb. 4, 2026parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH… Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
• Feb. 4, 2026Sterile Water for Irrigation… Class IIPresence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
• Jan. 28, 2026Icosapent Ethyl capsules… Class IISubpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
• Jan. 28, 2026Thyroid… Class IISubpotent Drug
• Jan. 28, 2026Furosemide Tablets… Class IIPresence of Foreign Substance
• Jan. 28, 2026Diclofenac Sodium Topical Gel… Class IIIFailed PH Specifications
• Jan. 21, 2026Lanreotide Injection… Class IIPresence of Particulate Matter.
• Jan. 21, 2026Advil a) Ibuprofen… and 26 more products Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
• Jan. 21, 2026AQ 120 Gfew… Class IIcGMP deviations.
• Jan. 21, 2026Levothyroxine Sodium Tablets… Class IIProduct Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
• Jan. 21, 2026TESTO-100 CIII (testosterone 100 mg)… Class IILack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
• Jan. 21, 2026Clindamycin Phosphate USP… Class IIIFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
• Jan. 21, 2026Fluocinolone Acetonide Solution Topical Solution USP… Class IIIFailed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
• Jan. 14, 2026Rosuvastatin Tablets… Class IIOut of specification for dissolution.
• Jan. 14, 2026ReBoost Nasal Spray… and 1 more product Class IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as…
• Jan. 14, 2026Oxycodone and Acetaminophen CII Tablets USP… and 1 more product Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
• Jan. 14, 2026ORL Kids Mouthwash… and 1 more product Class IIcGMP Deviations
• Jan. 14, 2026Dexamethasone Moxifloxacin… and 2 more products Class IIPresence of particulate matter - Glass like particles.
• Jan. 14, 2026Fesoterodine Fumarate… Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
• Jan. 9, 2026Modern Warrior Dietary supplement capsules marketed for metabolism moosting, improving brain function, and… Unapproved new drug found to contain undeclared 1,4-DMAA and aniracetam, and tianeptine
• Jan. 9, 2026Silintan Dietary supplement capsules marketed for relief of joint and body aches Unapproved new drug found to contain undeclared meloxicam
• Jan. 7, 2026traZODONE Hydrochloride Tablets… Class IIIFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
• Jan. 7, 2026Ondansetron Orally Disintegrating Tablets… Class IIDefective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
• Jan. 7, 2026Wegovy (semaglutide) Injection… and 1 more product Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
• Jan. 7, 2026BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG)… Class IILack of Assurance of Sterlity
• Dec. 31, 2025Merck Emend (aprepitant) for oral suspension… and 1 more product Class IIPresence of particulate matter: potential presence of metal particulates in the product.
• Dec. 24, 2025Ciclopirox Shampoo… Class IIFailed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
• Dec. 24, 2025Ondansetron ODT Tablets… Class IIDefective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
• Dec. 24, 2025Cisatracurium Besylate Injection USP… and 2 more products Class IIISubpotent product:out of specification assay results observed during long term stability testing.
• Dec. 24, 2025Baclofen Tablets USP… Class IIPresence of Foreign Tablets/Capsules
• Dec. 24, 20252% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and… and 6 more products Class IIDefective container: cracked/broken cartridges
• Dec. 22, 2025Virgo Rheumacare Capsules Elevated levels of lead
• Dec. 17, 2025Sertraline Hydrochloride Tablets USP… Class IIDefective container - seal not adhering to bottles
• Dec. 17, 2025Cinacalcet Hydrochloride Tablets… and 2 more products Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
• Dec. 17, 2025Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)… Class IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
• Dec. 17, 2025Nebivolol Tablets… Class IIICross Contamination with Other Products
• Dec. 17, 2025Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution… Class IIIncorrect Product Formulation
• Dec. 17, 2025Ganirelix Acetate Injection… Class IIFailed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
• Dec. 17, 2025Varenicline Tablets… Class IIISub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
• Dec. 17, 2025Lanthanum Carbonate chewable tablets… and 1 more product Class IIFailed stability specifications: Out of specification for hardness test
• Dec. 16, 2025MR7 Super 700000 Dietary supplement for male enhancement Undeclared Sildenafil and Tadalafil
• Dec. 16, 2025ReBoost, ClearLife Nasal spray, 0.68 fl oz Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.
• Dec. 10, 2025Duloxetine Delayed-Release Capsules… and 1 more product Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
• Dec. 10, 2025Haloperidol Lactate Injection… Class IILabeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
• Dec. 10, 2025Lanashield Skin Barrier… and 12 more products Class IIcGMP deviations
• Dec. 10, 2025Phenylephrine HCI… Class IICGMP Deviations
• Dec. 10, 2025Bisoprolol Fumarate and Hydrochlorothiazide Tablets… Class IIICross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
• Dec. 10, 2025Carton label: Testosterone Gel 1%… Class IIIDefective Container - A defect in the side-seal which allows leakage of product.
• Dec. 10, 2025Phytonadione Injectable Emulsion… Class IIFailed Stability Specifications: Observed OOS results: eg results for colour index
• Dec. 10, 2025ReBoost Nasal spray, 0.68 fl oz Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.
• Dec. 3, 2025Doctor… and 13 more products Class IICGMP Deviations
• Dec. 3, 2025Famotidine Injection… Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
• Dec. 3, 2025Walgreens Saline Nasal Spray WITH XYLITOL… Class IIMicrobial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
• Nov. 26, 2025POTASSIUM CHLORIDE Inj… and 1 more product Class ILabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
• Nov. 26, 2025Fentanyl citrate… Class IICGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
• Nov. 26, 20254-N-1 Skin Protectant… and 17 more products Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
• Nov. 26, 2025Bromocriptine Mesylate Capsules… Class IIFailed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate…
• Nov. 26, 2025NIACIN Extended-Release Tablets… Class IIFailed Dissolution Specifications
• Nov. 26, 2025Klarity-C Drops (Cyclosporine) 0.1%… Class IIISubpotent Drug
• Nov. 26, 2025Fesoterodine Fumarate… Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
• Nov. 12, 2025Acetaminophen 500mg Caffeine 65mg caplets… Class IILabeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
• Nov. 12, 2025clomiPRAMINE Hydrochloride… and 2 more products Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
• Nov. 12, 2025Amoxicillin and Clavulanate Potassium for Oral Suspension USP… Class IISubpotent drug; Clavulanate Potassium component
• Nov. 7, 2025Fresenius Kabi Famotidine Injection, USP 20 mg per 2 mL Out-of-specification endotoxin results
• Nov. 5, 2025Lisdexamfetamine Dimesylate Capsules… and 6 more products Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
• Nov. 5, 20250.9% SODIUM CHLORIDE Injection… Class IILack of Assurance of Sterility: Potential for flexible container leaks.
• Nov. 5, 2025Everolimus tablets 5mg… and 3 more products Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
• Nov. 5, 2025Espumil… Class IIILabeling: Not Elsewhere Classified
• Nov. 5, 2025Testosterone 25MG… and 14 more products Class IICGMP Deviations: Potential presence of metal particulate matter
• Nov. 5, 2025Sting Relief Swabs… Class IIProduct Mix-up
• Nov. 5, 2025Tylenol… Class IIDefective Container
• Nov. 5, 2025Semaglutide Injection… and 6 more products Class IILack of Assurance of Sterility
• Nov. 5, 2025R.E.C.K… Class IIPresence of Particulate Matter
• Nov. 5, 2025Desipramine Hydrochloride Tablets… and 5 more products Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
• Nov. 5, 2025Prazosin Hydrochloride… and 2 more products Class IICGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
• Nov. 5, 2025Prazosin Hydrochloride… and 2 more products Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
• Nov. 5, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
• Nov. 5, 2025HADLIMA (adalimumab-bwwd) injection… Class IILack of Assurance of Sterility.
• Nov. 3, 2025ICU Medical 20 mEq Potassium Chloride Injection Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection
• Oct. 29, 2025Taoscare Motion Sickness Patches 36-count box… Class IIMarketed Without an Approved NDA/ANDA
• Oct. 29, 2025Opdualag (nivolumab and relatlimab-rmbw) injection… Class IILack of Assurance of Sterility.
• Oct. 29, 2025Niacin Extended-release Tablets… Class IIFailed Dissolution Specifications
• Oct. 29, 2025Zicam" Medicated Fruit Drops Elderberry Flavor… Class IILabeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
• Oct. 29, 2025Bupropion Hydrochloride Extended-Release Tablets USP (XL)… Class IIFailed Tablet/Capsule Specifications
• Oct. 29, 2025Ketorolac Tromethamine Injection… Class IIPresence of Particulate Matter: Particulate matter identified as glass
• Oct. 29, 2025Medline… Class IISubpotent Drug
• Oct. 29, 2025Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %… Class IIFailed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
• Oct. 29, 2025Cetirizine Hydrochloride Tablets USP 10 mg… and 1 more product Class IIITablet/Capsules Imprinted with Wrong ID
• Oct. 29, 2025Gabapentin Capsules… and 1 more product Class IIFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
• Oct. 22, 2025Carbidopa… Class IIProduct mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…
• Oct. 22, 2025Fasenra (benralizumab) Injection… Class IILack of Assurance of Sterility:
• Oct. 22, 2025Sucralfate Tablets… Class IICGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot…
• Oct. 22, 2025Everolimus tablets 5mg… Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
• Oct. 22, 2025Hydromorphone HCL PF… and 2 more products Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
• Oct. 22, 2025Aloe Up Sport Performance Sunscreen Lotion SPF 30… Class IIcGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
• Oct. 22, 2025Viorele… Class IIFailed Impurities/Degradation Specifications
• Oct. 22, 2025Atorvastatin Calcium Tablets USP… and 3 more products Class IIFailed Dissolution Specifications
• Oct. 22, 2025Tavaborole Topical solution 5%… Class IIDiscoloration
• Oct. 22, 2025Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use… Class ISubpotent Drug: Testing revealed there was no oxytocin in the IV bag.
• Oct. 15, 2025Alpha Lipoic Acid for Injection… and 56 more products Class ILack of Assurance of Sterility
• Oct. 15, 2025Doxycycline Hyclate Tablets… Class IIFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
• Oct. 15, 2025Major ChlorproMAZINE Hydrochloride Tablets… and 4 more products Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
• Oct. 15, 2025Succinylcholine Chloride Injection… Class IIOut-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
• Oct. 15, 2025Norgestimate and Ethinyl Estradiol Tablets… Class IIFailed Content Uniformity Specifications
• Oct. 15, 2025Levothyroxine Sodium Tablets… Class IISubpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…
• Oct. 15, 2025Wyandotte… and 1 more product Class IIcGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
• Oct. 15, 2025Bevacizumab 1.75 mg/0.07 mL… Class IILack of assurance of sterility.
• Oct. 8, 2025Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution… and 1 more product Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
• Oct. 8, 2025Carbamazepine Extended-Release Tablets… Class IIFailed Dissolution Specifications.
• Oct. 8, 2025Entecavir Tablets… and 1 more product Class IIFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
• Oct. 1, 2025Readyprep PVP… Class IIISubpotent drug
• Oct. 1, 2025Dextroamphetamine Saccharate… and 4 more products Class IIIFailed Impurities/Degradation Specifications:
• Oct. 1, 2025ARTISAN OF SKIN (Benzoyl Peroxide 10%)… and 5 more products Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
• Oct. 1, 2025Azelaic Acid Gel… Class IICGMP Deviations: Market complaints received for gritty texture (grainy)
• Oct. 1, 2025Kroger 70% Isopropyl Alcohol… and 1 more product Class IIICross Contamination with Other Products.
• Oct. 1, 2025Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%)… Class IIcGMP Deviations
• Sept. 24, 2025Kit for the Preparation of Technetium Tc 99m Mertiatide… Class IIFailed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…
• Sept. 24, 2025Entecavir Tablets… and 1 more product Class IIFailed Impurity/Degradation Specifications
• Sept. 24, 2025Cyclobenzaprine Hydrochloride Tablets… Class ILabeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets…
• Sept. 24, 2025Sulfamethoxazole and Trimethoprim Tablets… Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
• Sept. 24, 2025Sterile Water For Injection USP… and 1 more product Class IILack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
• Sept. 24, 2025Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL)… Class IIcGMP deviations: Temperature excursion during transportation.
• Sept. 24, 2025chlorproMAZINE Hydrochloride Tablets… and 3 more products Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…
• Sept. 24, 2025bevacizumab (Avastin) Injection… Class IILack of Assurance of Sterility
• Sept. 24, 2025Aripiprazole Tablets… Class IISuperpotent drug
• Sept. 17, 2025chloroproMAZINE Hydrochloride Tablets… and 1 more product Class IIPresence of a foreign substance.
• Sept. 17, 2025Dextroamphetamine Saccharate… Class IIPresence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and…
• Sept. 17, 2025Ultra Violette… and 1 more product Class IISubpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
• Sept. 17, 2025Chlorpromazine Hydrochloride Tablets… and 9 more products Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
• Sept. 17, 2025Neuroquell & Neuroquell Plus… Class IIcGMP violations
• Sept. 17, 2025Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only… Class IITemperature Abuse
• Sept. 17, 2025Sulfamethoxazole and Trimethoprim… and 1 more product Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
• Sept. 17, 2025Succinylcholine Chloride Injection… Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
• Sept. 17, 2025Iodo Blanco Iodides… Class IIDefective Container: broken or leaking bottles.
• Sept. 17, 2025Duloxetine Delayed-Release Capsules… Class IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
• Sept. 17, 20254.2% Sodium Bicarbonate Injection… Class IIFailed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
• Sept. 10, 2025Lactated Ringers's Injection USP… and 1 more product Class IPresence of Particulate Matter
• Sept. 10, 2025Sulfamethoxazole and Trimethoprim Tablets… and 4 more products Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism.…
• Sept. 10, 2025KIMMTRAK (tebentafusp-tebn) Injection… Class IISubpotent Drug
• Sept. 10, 2025DermaKleen… and 3 more products Class IMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
• Sept. 10, 2025Semaglutide… and 3 more products Class IISubpotent Drug
• Sept. 3, 2025Medline Alcohol Prep Pads… and 5 more products Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
• Sept. 3, 2025Lisdexamfetamine Dimesylate Capsules… Class IILabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
• Sept. 3, 2025Sucralfate Tablets… Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot…
• Sept. 3, 2025Enoxaparin Sodium Injection… Class IICorrect Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
• Sept. 3, 2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL)… Class IIDiscoloration
• Aug. 29, 2025Green Lumber Dietary Supplement Undeclared prescription drug-Tadalafil
• Aug. 28, 2025DermaRite Hand Sanitizers, Cleansers, Skin Protectants, Deodorant Device & Drug Safety - Potential Burkholderia cepacian contamination
• Aug. 27, 2025Tavaborole Topical Solution 5%… Class IIDiscoloration
• Aug. 27, 2025Carvedilol Tablets USP… Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
• Aug. 27, 2025Albuterol Sulfate… Class IIIFailed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…
• Aug. 27, 2025Sensodyne PRONAMEL (Potassium nitrate 5%… Class IIILabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh…
• Aug. 27, 2025Vial Label: Epinephrine Injection… and 1 more product Class IILack of Assurance of Sterility.
• Aug. 27, 2025BZK Antiseptic Towelette… Class IILack of Assurance of Sterility.
• Aug. 27, 2025Unichem Pharmaceuticals Cyclobenzaprine Hydrochloride Tablets USP 10 mg Device & Drug Safety – Mislabel
• Aug. 20, 2025Carvedilol Tablets… and 1 more product Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
• Aug. 20, 2025Lactated Ringer's Injection USP… and 1 more product Class IILack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
• Aug. 20, 2025Belsomra (suvorexant) tablets… Class IIFailed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the…
• Aug. 20, 2025Theophylline extended-release tablets 400mg… Class IIFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the…
• Aug. 20, 2025Metoprolol Tartrate Tablets… and 1 more product Class IICGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
• Aug. 20, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
• Aug. 20, 2025Carvedilol Tablets… and 2 more products Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
• Aug. 20, 2025Amlodipine and Olmesartan Medoxomil Tablets… Class IIFailed Dissolution Specifications: low dissolution results
• Aug. 20, 2025Levoxyl (levothyroxine sodium tablets… Class IISubpotent drug
• Aug. 19, 2025B. Braun Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL Due to the presence of particulate matter.
• Aug. 13, 2025Spironolactone Tablets… Class IIPresence of foreign substance: identified as aluminum.
• Aug. 13, 2025Xolair (omalizumab injection)… and 2 more products Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
• Aug. 13, 2025Duloxetine D/R… and 1 more product Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
• Aug. 13, 2025Doxepin Hydrochloride Capsules… Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
• Aug. 13, 2025Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol… and 12 more products Class IILack of Processing Controls.
• Aug. 13, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
• Aug. 9, 2025DermaKleen, Dermasarra, Kleenfoam, and Perigiene OTC antiseptic lotion soaps, external analgesics… Contamination with Burkholderia cepacia
• Aug. 6, 2025Lorazepam Injection… Class IIFailed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
• Aug. 6, 2025Sucralfate Tablets… Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot…
• Aug. 6, 2025Cinacalcet Tablets 90 mg… Class IIFailed Dissolution Specifications.
• Aug. 6, 2025Bicillin L-A (penicllin G benzathine injectable suspension)… and 1 more product Class IICGMP Deviations; particulates identified during visual inspection
• Aug. 6, 2025Timolol Maleate Ophthalmic Solution USP… Class IIDefective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
• Aug. 6, 2025Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg… Class IILabeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
• July 30, 2025Budesonide Inhalation Suspension… Class IILack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
• July 30, 2025PROLIA (denosumab)… and 2 more products Class IICGMP Deviations; potential temperature excursions due to transit delays
• July 30, 2025clomiPRAMINE Hydrochloride Capsules USP 25 mg… Class IIFailed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
• July 30, 2025Epinephrine Lidocaine HCL… and 1 more product Class IISub-Potent Drug: Subpotent assay results during stability testing.
• July 23, 2025Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with… and 2 more products Class IICGMP Deviations
• July 23, 2025Rizatriptan Benzoate Tablets… and 1 more product Class IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
• July 23, 2025Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg… Class IIProduct Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
• July 23, 2025Peripheral Parenteral Nutrition… Class IILack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently…
• July 23, 2025Omeprazole Delayed-release Capsules… Class IIPresence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
• July 23, 2025Levothyroxine Sodium Tablets… and 6 more products Class IISubpotent Drug: Assay below the approved specification
• July 23, 2025Testosterone 200 mg Pellet packaged in 1mL amber vials… Class IIILabeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
• July 23, 2025Lisdexamfetamine Dimesylate Capsules… Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability…
• July 16, 2025B Natural Organics… and 3 more products Class IIcGMP deviations
• July 16, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
• July 16, 2025Famciclovir Tablets… Class IIIPresence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
• July 14, 2025Nostrum Laboratories Sucralfate Tablets USP 1 gram Company closure and discontinuation of quality activities.
• July 9, 2025Cefazolin for Injection… and 1 more product Class ILabeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection…
• July 9, 2025Pitavastatin Tablets… and 1 more product Class IIIFailed Impurity/Degradation Specifications
• July 9, 2025Pitavastatin Tablets… and 1 more product Class IIIFailed Impurities/Degradation Specifications.
• July 9, 2025Metoprolol Succinate Extended-Release Tablets… Class IIFailed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH)…
• July 9, 2025Gabapentin Capsules… and 1 more product Class IIDefective container; blister packaging inadequately sealed.
• July 9, 2025Zicam Cold Remedy Medicated Nasal Swabs… and 2 more products Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
• July 9, 2025LIDOcaine HCl Injection… and 5 more products Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
• July 2, 2025Testo-200… Class IIMarketed Without an Approved NDA/ANDA
• July 2, 2025Ketorolac Tromethamine Ophthalmic Solution… and 2 more products Class IILack of Assurance of Sterility
• July 2, 20250.9% Sodium Chloride Injection USP… Class IILack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
• July 2, 20250.9% Sodium Chloride Injection… Class IILack of Assurance of Sterility
• July 2, 2025DOBUTamine Injection… Class IIDiscoloration; discolored solution from cracked vials
• July 2, 2025Methylcobalamin Injectable… and 13 more products Class IILack of Assurance of Sterility
• July 2, 2025Metoclopramide Tablets… Class IIPresence of foreign tablets/capsules.
• June 27, 2025Sandoz Cefazolin for Injection, USP, 1 gm vial Potential Presence of Penicillin G Potassium Injection Vial
• June 25, 2025Unavy Acido Hialuronico… and 1 more product Class IMarketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…
• June 25, 2025Gentamicin Injection… Class IIFailed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
• June 25, 2025Acetaminophen Tablets… Class IIcGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
• June 18, 2025Icosapent Ethyl Capsules 1 gram… Class IIFailed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation…
• June 18, 2025Sulfamethoxazole and Trimethoprim Tablets… Class IMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
• June 18, 2025Levothyroxine Sodium Tablets… Class IIIPresence of a foreign substance: black hair found embedded in tablet.
• June 18, 2025Cephalexin for Oral Suspension… and 1 more product Class IIFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
• June 18, 2025Male Ultra… and 4 more products Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
• June 18, 2025Ezetimibe and Simvastatin Tablets… Class IIIFailed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…
• June 18, 2025Chlorthalidone Tablets… Class IIFailed Dissolution Specifications
• June 18, 2025Celecoxib Capsules… Class IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg…
• June 18, 2025Celecoxib Capsules… Class IIPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
• June 11, 2025Spectrum Advanced Gel Hand Sanitizer… Class IISubpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
• June 11, 2025Lacosamide Oral Solution… Class IIDefective Container: This recall is being initiated due to a leaking unit stored horizontally.
• June 11, 2025Fluoxetine Tablets… and 1 more product Class IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
• June 11, 2025Indomethacin Extended-Release Capsules… Class IIcGMP deviations
• June 6, 2025Zicam® and Orajel™ Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs Microbial contamination
• June 4, 2025Endurance Boost With Horny Goat Weed… Class IMarketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
• June 4, 2025Theophylline (Anhydrous) Extended-Release Tablets… Class IIOOS results reported for the Dissolution (by UV) test.
• June 4, 2025Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC… and 3 more products Class IICGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
• June 4, 2025Bromfenac Ophthalmic Solution 0.09%… Class IIFailed Impurities/Degradation Specifications
• June 4, 2025Amneal Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg Microbial contamination
• May 28, 2025Indomethacin Extended-Release Capsules USP… and 1 more product Class IIcGMP deviations
• May 28, 2025Airsupra (albuterol and budesonide) inhalation aerosol… Class IIDefective delivery system
• May 28, 2025Esomeprazole Magnesium for Delayed-Release Oral Suspension… and 1 more product Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
• May 28, 2025BD ChloraPrep Clear… Class IILack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
• May 28, 2025Artridon Glucosamine (menthol 2% and Methyl Salicylate 15%… and 19 more products Class IICGMP Deviations
• May 22, 2025Unavy & Umovy Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico (30 caplets/850 mg) The product contains undeclared Dexamethasone, Diclofenac and Omeprazole
• May 21, 2025Testosterone Cypionate Injection… Class IILack of Assurance of Sterility
• May 21, 2025La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action… and 2 more products Class IIChemical Contamination: This recall has been initiated due to detected trace levels of benzene.
• May 14, 2025TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%)… and 4 more products Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
• May 14, 2025Clindamycin HCl Capsule… Class IICGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
• May 14, 2025temper tamer… Class IICGMP Deviations
• May 14, 2025FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL… Class IILack of Assurance of Sterility
• May 14, 2025Artificial Tears Ophthalmic Solution… and 4 more products Class IIcGMP deviations and lack of assurance of sterility.
• May 14, 2025Timolol Maleate Ophthalmic Solution USP… Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
• May 14, 2025Ropivacaine Hydrochloride Injection… Class IPresence of Particulate Matter
• May 7, 2025Medroxyprogesterone Acetate Injectable Suspension… and 1 more product Class IISevere thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified…
• May 7, 2025niCARdipine Hydrochloride Injection… and 1 more product Class IILack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
• May 7, 2025Levothyroxine Sodium Tablets… and 3 more products Class IISubpotent
• May 7, 2025Wegovy (semaglutide) injection… Class IITemperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
• May 7, 2025Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL)… Class IILabeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024…
• May 7, 2025Clindamycin Hydrochloride Capsules… Class IIcGMP Deviations
• May 7, 2025Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL)… and 1 more product Class IIOut-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
• May 6, 2025Endurance Boost Dietary supplement for male performance and energy Undeclared Propoxyphenylsildenafil, Sildenafil
• April 30, 2025Duloxetine Delayed-Release Capsules USP… and 1 more product Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
• April 30, 2025Bimatoprost powder… Class IICGMP Deviations
• April 30, 2025HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)… Class IIISuperpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
• April 30, 2025DoloDent Maximum Strength Toothache Drops… and 5 more products Class IIcGMP deviations
• April 30, 2025Clindamycin HCl… Class IICGMP Deviations
• April 30, 2025clomiPRAMINE hydrochloride Capsules USP… Class IIFailed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
• April 30, 2025Hemopropin Ointment… and 1 more product Class IICGMP Deviations
• April 30, 2025Glycopyrrolate… and 4 more products Class IILack of Assurance of Sterility: Leaking/damaged syringes.
• April 30, 2025Haloperidol Decanoate Injection… and 2 more products Class IILack of assurance of sterility. Bacterial contamination detected in some media fill units
• April 23, 2025ChlorproMAZINE Hydrochloride Tablets… Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
• April 23, 2025Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL)… Class ILABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
• April 23, 2025Ciprofloxacin Ophth Solution… Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
• April 23, 2025Testosterone Cypionate Injection… Class IIcGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
• April 23, 2025Unisom… Class IICGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…
• April 18, 2025Amneal Pharmaceuticals LLC. Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag Product may contain an inert fiber identified as polypropylene fibers from the IV bag
• April 16, 2025chlorproMAZINE Hydrochloride Tablets… Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
• April 16, 2025Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%)… and 1 more product Class IIChemical contamination: Presence of benzene
• April 16, 2025Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL)… and 4 more products Class IILack of Assurance of Sterility: Media fill with bacterial contamination
• April 16, 20250.9% Sodium chloride Irrigation USP… Class IIPresence of Particulate Matter
• April 16, 2025Fenofibrate Capsules 67 mg… and 38 more products Class IICGMP Deviations
• April 16, 2025Sofosbuvir and Velpatasvir… Class IIDefective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
• April 16, 2025Gabapentin Capsules… and 1 more product Class IIICross Contamination
• April 16, 2025Venlafaxine Tablets… Class IIPresence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
• April 9, 2025chlorproMAZINE Hydrochloride Tablets… Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
• April 9, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
• April 9, 2025Voriconazole Tablets… Class IIcGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
• April 9, 2025Atorvastatin Calcium Tablets USP 40 mg… Class IIFailed dissolution specifications: lower than specifications
• April 9, 2025Tropicamide… Class IIISub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
• April 9, 2025Tolterodine Tartrate Extended-Release Capsules… Class IIIFailed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
• April 2, 20258.4% Sodium Bicarbonate Injection… Class IILack of Assurance of Sterility
• April 2, 2025[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution… Class IILabeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
• April 2, 2025SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium… and 2 more products Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
• April 2, 2025babyganics… Class IIFailed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was…
• April 2, 2025fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl… and 2 more products Class IILack of Assurance of Sterility
• April 2, 2025Testosterone Gel 1%… and 1 more product Class IIPresence of foreign substance: Presence of Benzene.
• April 2, 2025Metformin Hydrochloride Extended- Release 500Mg… Class IIPresence of Foreign Tablets/Capsules.
• March 26, 2025Levothyroxine Sodium Tablets… and 1 more product Class IISuper-Potent Drug: Out of specification potency results were obtained.
• March 26, 2025Medline Alcohol Prep Pads… and 1 more product Class IISubpotent Drug
• March 26, 2025Prasugrel Tablets… Class IIFailed Dissolution Specifications
• March 26, 2025Neupogen (filgrastim) For Injection… and 1 more product Class IIStability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
• March 26, 2025Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl… and 1 more product Class IIChemical contamination: presence of benzene
• March 26, 2025Ciprofloxacin Ophthalmic Solution USP… Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
• March 26, 2025Vitality… Class IMarketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
• March 26, 2025Prasugrel Tablets… Class IIFailed Dissolution Specifications - low dissolution results
• March 26, 2025Cinacalcet Hydrochloride Tablets 30 mg… and 1 more product Class IICGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
• March 26, 2025Duloxetine Delayed-Release Capsules… Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
• March 19, 2025Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%… and 1 more product Class IIChemical Contamination
• March 19, 2025Walgreens… Class IIChemical Contamination: Presence of benzene
• March 19, 2025Zapzyt… Class IIChemical Contamination: Presence of benzene.
• March 19, 2025PHENYLephrine added to 0.9% sodium chloride… Class IPresence of Particulate Matter
• March 19, 2025Duloxetine Delayed-Release Capsules… and 2 more products Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
• March 19, 2025POTASSIUM CHLORIDE Inj… and 1 more product Class ILabeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10…
• March 19, 2025Unisom… Class IICGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug…
• March 19, 2025Bimatoprost NDC# 82187-1001-1 Container description: The product… and 5 more products Class IICGMP Deviations
• March 19, 2025BD ChloraPrep Clear 1mL Applicators… Class INon-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
• March 19, 2025Livalo (pitavatstatin) tablets… Class IIIPresence of foreign tablets/capsules
• March 19, 2025Sodium Chloride Injection 9%… Class IILack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
• March 13, 2025Dr. Reddy’s Levetiracetam in Sodium Chloride Injection Mislabeling of infusion bag
• March 12, 2025Nelarabine Injection… and 1 more product Class IIFailed Impurities/Degradation Specifications
• March 12, 2025Ergocalciferol… and 4 more products Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• March 12, 2025Morphine Sulfate Extended-Release Tablets… Class IIFailed Dissolution Specifications
• March 5, 2025Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe… Class IILack of Assurance of Sterility: due to a quality control process deviation
• March 5, 2025ViaMed Alcohol Prep Pads… Class IILack of assurance of sterility and cGMP deviations observed at the manufacturing site.
• March 5, 2025Estradiol Gel… Class IIDefective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
• March 3, 2025Vitality male enhancement dietary supplement capsules Undeclared Sildenafil and Tadalafil
• Feb. 26, 2025Fentanyl Transdermal System CII… Class IDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
• Feb. 26, 2025Atomoxetine Capsules… and 13 more products Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
• Feb. 26, 2025Phenylephrine HCl Injection… Class IPresence of Particulate Matter.
• Feb. 26, 2025Silodosin Capsules… Class IISubpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT…
• Feb. 26, 2025Lorazepam Tablets… and 2 more products Class IIFailed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
• Feb. 26, 2025fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII… Class IILack of Assurance of Sterility
• Feb. 26, 2025Natural Dior LLC Dietary Supplement Undeclared Tadalafil
• Feb. 25, 2025CAPS Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag Due to visible black particulate matter
• Feb. 25, 2025SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Microbial contamination of the product with Staphylococcus aureus (S. aureus)

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