Pfizer recalls

• Aug. 27, 2025Vial Label: Epinephrine Injection… and 1 more product Class IILack of Assurance of Sterility.
• Aug. 20, 2025Levoxyl (levothyroxine sodium tablets… Class IISubpotent drug
• Aug. 6, 2025Bicillin L-A (penicllin G benzathine injectable suspension)… and 1 more product Class IICGMP Deviations; particulates identified during visual inspection
• July 2, 2025DOBUTamine Injection… Class IIDiscoloration; discolored solution from cracked vials
• July 3, 2024Buprenorphine Hydrochloride Injection… and 1 more product Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
• Jan. 31, 2024Bleomycin for Injection… Class IPresence of particulate matter: glass
• Jan. 24, 20244.2% Sodium Bicarbonate Injection… and 2 more products Class IPresence of Particulate Matter; identified as glass
• Nov. 15, 20234.2% Sodium Bicarbonate Injection… and 2 more products Class IPresence of Particulate Matter: identified as glass.
• April 19, 2023MEKTOVI (binimetinib) tablets… Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is…
• March 16, 2023Nurtec® ODT (rimegepant) orally disintegrating tablets, 75mg 8-Unit Dose blister pack The recalled prescription drugs must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the…
• Feb. 1, 2023Vancomycin Hydrochloride for Injection… Class IPresence of Particulate Matter: Glass particulate matter detected in injectable.
• Jan. 11, 2023Heparin Sodium 2,000… Class IILack of assurance of sterility: Bags have the potential to leak.
• Oct. 12, 2022Aminophylline Injection… Class IIPresence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
• Sept. 21, 2022PROPOFOL Injectable Emulsion… Class IPresence of particulate matter
• Aug. 3, 2022Propofol Injectable Emulsion… Class IPresence of particulate matter: particulate identified as a beetle.
• May 25, 2022Accupril (Quinapril HCl Tablets) 10 mg… and 2 more products Class IICGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
• April 22, 2022Pfizer Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg Due to N-Nitroso-Quinapril Content
• April 13, 2022Accuretic (quinapril HCl/hydrochlorothiazide) Tablets… and 7 more products Class IICGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
• Dec. 8, 20215% Dextrose Injection… Class IILack of sterility assurance: bag has the potential to leak.
• Sept. 29, 2021Chantix (varenicline) tablets 0.5mg/1mg… and 3 more products Class IICGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
• Sept. 16, 2021Chantix Varenicline tablets N-nitroso-varenicline above acceptable daily intake level
• Aug. 11, 2021Chantix (varenicline) tablets… and 2 more products Class IICGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
• July 19, 2021Chantix Smoking cessation treatment N-Nitroso Varenicline content above ADI level
• June 9, 20210.5% Bupivacaine Hydrochloride Injection… and 1 more product Class ILabeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and…
• May 26, 2021Sterile Water for Inj… Class IIPresence of Particulate Matter: particulate matter identified as an insect in one vial.
• Aug. 12, 2020Fentanyl Citrate Inj… Class IILack of Assurance of Sterility; potential loose metal overseal crimp defects.
• July 1, 2020Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg… Class IIIFailed Dissolution Specifications
• June 17, 2020Unasyn (ampicillin sodium/sulbacatam) for injection… Class IIPresence of Particulate Matter: particulate matter identified after reconstitution.
• March 11, 2020Elelyso (taliglucerase alfa) for injection… Class IILack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while…
• Feb. 19, 2020Caduet (amlodipine besylate/atorvastatin calcium) Tablets… and 1 more product Class IIDefective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
• Feb. 19, 2020Fentanyl Citrate Inj… Class IIDefective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
• Dec. 18, 201925% Dextrose Injection… Class IILabeling: Incorrect or Missing Lot and/or expiration date.
• Oct. 16, 201910% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection… Class IILack of Assurance of Sterility: Bag has the potential to leak.
• Oct. 2, 2019ethosuximide capsules… and 1 more product Class IIILabeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021…
• Sept. 18, 2019Bacteriostatic Water for Injection… Class IILack of Assurance of Sterility
• Sept. 4, 2019RELPAX (eletriptan HBr) tablets… Class IIMicrobial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
• July 24, 2019Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose… and 1 more product Class IILack of Assurance of Sterility: Bags have the potential to leak.
• May 22, 2019Relpax (eletriptan HBr) 40 mg… Class IIILabeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains…
• April 10, 20198.4% Sodium Bicarbonate Injection… Class IPresence of Particulate Matter; glass particulates
• April 10, 2019Cleocin Phosphate (clindamycin injection)… and 5 more products Class IIIFailed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…
• Dec. 26, 2018Levoxyl (levothyroxine sodium tablets… Class IISuperpotent Drug.
• Dec. 12, 2018Thermacare Muscle Pain Therapy HeatWraps: a)… and 2 more products Class IIThe firm received complaints of the wrap coming apart and leaking granular material
• Oct. 31, 2018Meropenem for Injection… Class IILack of assurance of sterility: loss of container integrity.
• Oct. 17, 2018Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL… Class IICorrect Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC…
• Oct. 17, 2018Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle… Class IICGMP Deviations; rejected product was used to manufacture final bulk lot
• Oct. 10, 2018Elelyso (taliglucerase alfa) for injection… Class IILack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while…
• Sept. 19, 2018Argatroban Injection… Class IIIFailed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
• Aug. 8, 2018Daptomycin for Injection… Class IIMicrobial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to…
• March 21, 2018Hydromorphone… and 1 more product Class INon-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
• Jan. 10, 2018diphenoxylate hydrochloride and atropine sulfate tablets… and 1 more product Class ISUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
• Dec. 27, 2017Vancomycin Hydrochloride for Injection… Class IPresence of Particulate Matter: glass particulate found in vial
• Oct. 11, 2017Deferoxamine Mesylate for injection… Class IIICGMP Deviations: Firm failed to control impurity for color change at the API stage.
• Oct. 4, 2017Sterile Water for Injection… Class IINon-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
• Sept. 27, 2017HYDROmorphone HCl Injection… and 1 more product Class IILack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
• Sept. 27, 2017Quillivant XR methylphenidate HCl… and 1 more product Class IIIFailed Dissolution Specifications
• March 29, 2017Quillivant XR (methylphenidate HCl) for extended-release oral… and 2 more products Class IIIFailed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
• March 22, 2017Protonix I.V… Class IIISubpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
• Jan. 18, 2017Cytotec (misoprostol) Tablets… Class IIIFailed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
• Nov. 30, 2016LEVOXYL(R) (levothyroxine sodium tablets… Class IISuperpotent
• Oct. 5, 2016PREMARIN (conjugated estrogen tablets… Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
• June 1, 2016Zoloft (sertraline HCl) tablets… Class IIFailed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
• April 6, 2016Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz… Class IIILabeling: Label Mix-Up
• Feb. 10, 2016Lyrica (pregabalin) capsules… and 1 more product Class IIFAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged…
• Dec. 16, 2015Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg… Class IIIFailed Dissolution Specification
• Nov. 4, 2015Xanax (alprazolam) tablets… Class IISubpotent Drug
• March 11, 2015Oxecta(TM) (oxycodone HCl) tablets… and 1 more product Class IIIFailed Impurities/Degradation Specifications
• Dec. 17, 2014Tikosyn (dofetilide) 125 mcg (0.125 mg)… Class IIFailed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
• Nov. 12, 2014TORISEL Kit (temsirolimus) injection… Class IIICrystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold…
• Aug. 20, 2014Depo-Medrol (methylprednisolone acetate injectable suspension USP)… Class IIIFailed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is…
• Aug. 6, 2014Cardura XL (doxazosin mesylate extended release tablets… Class IIIFailed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
• July 23, 2014VIRACEPT (R) (nelfinavir mesylate) Tablets… Class IIILabeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is…
• June 11, 2014GREENSTONE BRAND fluconazole for Oral Suspension… Class IIDefective Container: Tamper evident ring failures discovered on some bottles.
• April 30, 2014Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules… Class IIPresence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg…
• Feb. 12, 2014Glucotrol XL (glipizide) extended release tablets… Class IIIFailed Dissolution Specification; 8 hr stability timepoint
• Jan. 22, 2014Zithromax (azithromycin for injection)… Class IIIFailed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
• July 10, 2013Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets… and 1 more product Class IIIFailed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots…
• June 26, 2013Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg… Class IIIFailed Dissolution Specification
• April 24, 2013Levoxyl (levothyroxine sodium) tablets… and 10 more products Class IIChemical contamination: emission of strong odor after package was opened..
• April 3, 2013TORISEL Kit (temsirolimus) injection… Class IIILack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
• July 2, 1996PureSilk Shave Gel for women Laceration

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