Sun Pharmaceutical Industries recalls

• June 17, 2026DOXOrubin Hydrochloride Liposome injection… Class IPresence of Particulate matter: Particulate matter identified as glass.
• 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…
• May 13, 2026Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Presence of glass particles
• 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.
• 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%.
• 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.
• 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…
• 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…
• Aug. 13, 2025Spironolactone Tablets… Class IIPresence of foreign substance: identified as aluminum.
• 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…
• April 16, 2025Gabapentin Capsules… and 1 more product Class IIICross Contamination
• March 12, 2025Morphine Sulfate Extended-Release Tablets… Class IIFailed Dissolution Specifications
• July 24, 2024Nitrofurantoin Capsules… Class IIFailed Dissolution Specifications
• July 10, 2024Decitabine for Injection 50mg per vial… Class IICGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
• May 29, 2024Xelpros (latanoprost ophthalmic emulsion) 0.005%… Class IIIFailed Release Testing: Out of specification for particulate matter test.
• May 15, 2024Amphotericin B Liposome for Injection… Class IIOut of specification for assay
• March 20, 2024Febuxostat Tablets 40mg… and 1 more product Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
• March 6, 2024Mesalamine Extended-Release Capsules… Class IIFailed Dissolution Specifications: Out of specification for dissolution.
• Jan. 31, 2024Cinacalcet Tablets 60mg… and 10 more products Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
• Dec. 20, 2023Liothyronine Sodium Tablets… Class IIFailed Impurities/Degradation Specifications
• Dec. 13, 2023buPROPion Hydrochloride Extended-Release Tablets… Class IIIFailed Dissolution Specifications
• Nov. 8, 2023Liothyronine Sodium Tablets… and 1 more product Class IIFailed Impurities/Degradation Specifications.
• Oct. 25, 2023Bupropion Hydrochloride Extended-Release Tablets USP (SR)… Class IIIFailed Dissolution Specifications
• Sept. 27, 2023Cequa (cyclosporine ophthalmic solution) 0.09%… Class IIISubpotent: Out of Specification result observed for low assay
• Aug. 16, 2023Dofetilide Capsules 500 mcg (0.5mg)… Class IIIOut of Specification result observed in content uniformity testing
• Aug. 2, 2023Methylphenidate Hydrochloride Tablets… Class IIPresence of Foreign Substance: Metal embedded in a tablet.
• July 26, 2023Loteprednol Etabonate Ophthalmic Suspension… Class IIISuperpotent Drug: Out of Specification (OOS) results observed for unit dose content.
• July 19, 2023Tiagabine Hydrochloride Tablets… Class IIFailed Impurities: Out of Specification (OOS) result observed during Related Substances testing
• July 5, 2023Amphotericin B Liposome for Injection… Class IISubpotent drug
• June 14, 2023Buprenorphine Sublingual Tablets… Class IICGMP Deviations
• May 31, 2023buPROPrion Hydrochloride Extended-Release Tablets… Class IIFailed Dissolution Specifications; during stability testing
• May 3, 2023Fyremadel (ganirelix acetate) injection… Class IIPresence of Particulate Matter: A piece of glass was found in a prefilled syringe.
• April 19, 2023Norepinephrine Bitartrate Injection… Class IIIFailed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity…
• March 29, 2023Dofetilide Capsules… Class IIIFailed Content Uniformity Specifications
• Feb. 8, 2023Diltiazem Hydrochloride Extended-Release Capsules… Class IIFailed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
• Dec. 28, 2022Oxcarbazepine Tablets 600mg… Class IIPresence of foreign substance
• Nov. 30, 2022Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only… Class IIDiscoloration
• Nov. 9, 2022Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg… Class IIPresence of Foreign Substance
• Oct. 5, 2022Esomeprazole Magnesium Delayed-Release Capsules… and 1 more product Class IIISuperpotent Drug: Out of specification for assay at the 12-month timepoint.
• Aug. 3, 2022Divalproex Sodium Delayed-Release Tablets… Class IIFailed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
• July 20, 2022Testosterone Cypionate Injection… Class IIcGMP - Water leakage
• July 13, 2022Testosterone Cypionate Injection… Class IICGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
• June 29, 2022Clonazepam Orally Disintegrating Tablets… Class IIFailed Tablet/Capsule Specification; oversized tablet found in a bottle
• June 29, 2022Testosterone Cypionate Injection… Class IILack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
• June 29, 2022Testosterone Cypionate Injection… Class IICGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause…
• June 22, 2022medroxyPROGESTERone Acetate Injectable Suspension… and 4 more products Class IILack of assurance of sterility
• June 16, 2022Kroger Acetaminophen, 100 count bottles The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the…
• May 18, 2022buPROPion Hydrochloride Extended-Release Tablet… and 1 more product Class IIIPresence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be…
• April 13, 2022Cequa (cyclosporine ophthalmic solution) 0.09%… Class IIISubpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
• Feb. 23, 2022Chlorthalidone Tablets USP 25 mg… Class IIForeign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
• Jan. 12, 2022Pregabalin Capsules… Class IIFailed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical…
• Nov. 17, 2021Tadalafil Tablets… and 1 more product Class IIIncorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
• Nov. 3, 2021Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine… and 1 more product Class IIIFailed Moisture Limits
• Aug. 18, 2021Venlafaxine Tablets… Class IIPresence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
• May 26, 2021Cequa (cyclosporine ophthalmic solution) 0.09%… Class IIISubpotent and Presence of Particulates .
• May 19, 2021Metformin HCl Extended-Release Tablets… Class IIPresence of foreign substance: identified as activated carbon.
• April 21, 2021Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor… Class IIMicrobial Contamination of Non-Sterile Product
• April 14, 2021Metformin HCl Extended-Release Tablets… Class IIIFailed Moisture Limits: Out of specification for water content
• April 14, 2021Ganirelix Acetate Injection… Class IIFailed Impurities/Degradation Specifications
• March 10, 2021Cequa (cyclosporine ophthalmic solution) 0.09%… Class IIISubpotent
• Feb. 17, 2021Pantoprazole Sodium for Injection 40mg/vial For I.V… Class IIIFailed Impurity/Degradation Specifications
• Feb. 3, 2021Testosterone Cypionate Injection… Class IIIIncorrect Labeling: Incorrect lot number on secondary packaging
• Oct. 7, 2020RIOMET ER (metformin hydrochloride for extended-release oral suspension)… Class IICGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
• Sept. 23, 2020Riomet ER Metformin Hydrochloride for Extended-Release Oral Suspension Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
• Aug. 5, 2020Clonazepam Orally Disintegrating Tablets… Class IIICross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
• March 25, 2020Atorvastatin Calcium Tablets… Class IIPresence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
• March 25, 2020Doxycycline Capsules… and 1 more product Class IICGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
• Jan. 22, 2020Testosterone Cypionate for Injection… and 1 more product Class IIcGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
• Jan. 22, 2020Sumatriptan Succinate Tablets… and 1 more product Class IIFailed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
• June 26, 2019Allergy Relief D… and 3 more products Class IITesting of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or…
• Feb. 6, 2019BromSite (bromfenac ophthalmic solution) 0.075%… Class IIBromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
• Jan. 30, 2019Loperamide HCL Tablets USP… Class IIILabeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains…
• Jan. 16, 2019Vecuronium Bromide for Injection 10 mg*… and 1 more product Class IPresence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
• Dec. 26, 2018Absorica (Isotretinoin) Capsules 30 mg USP… Class IIISubpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
• Aug. 1, 2018Testosterone Cypionate Injection… Class IIPresence of Particulate Matter: organic and inorganic compounds detected in vials of product.
• July 25, 2018Metformin Hydrochloride Extended Release Tablets… Class IIPresence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter…
• May 23, 2018Riomet (metformin hydrochloride oral solution)… Class IIILabeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient…
• May 23, 2018Sulfamethoxazole and Trimethoprim Tablets USP… Class IIPresence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a…
• Feb. 21, 2018Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray)… Class IIISun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for…
• Jan. 31, 2018DOXOrubicin Hydrochloride Liposome Injection… Class IILack Of Assurance Of Sterility
• Dec. 20, 2017Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL… Class IIMicrobial Contamination of Non-Sterile Products
• May 31, 2017Children's Cetirizine Hydrochloride Chewable Tablets… Class IIIFailed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
• May 17, 2017Olanzapine Tablets… and 3 more products Class IIIFailed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
• March 29, 2017Testosterone Cypionate Injection… Class IIPresence of Particulate Matter
• March 8, 2017Alfuzosin Hydrochloride Extended-release Tablets… Class IIPresence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the…
• Feb. 8, 2017Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88)… Class IIFailed Dissolution Specifications
• Feb. 1, 2017buPROPion Hydrochloride Extended-release Tablets… and 1 more product Class IIIFailed Dissolution Specifications; 18 month stability time point
• Nov. 30, 2016KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol… Class IIIFailed Stability Specifications: Low Out of Specification results for alcohol content.
• Oct. 12, 2016buPROPion Hydrochloride Extended-release Tablets… Class IIIFailed Dissolution Specifications
• Sept. 28, 2016Carvediol Tablets… and 3 more products Class IIIFailed Impurities/Degradation Specifications
• July 27, 2016buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun… Class IIIFailed Dissolution Specifications
• July 17, 2013Nimodipine Capsules 30 mg… Class IICrystallization; crystallized nimodipine

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