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Pfizer Inc FDA Recalls
41 recalls on file across drugs, 11 of them Class I and 18 still open. Matched by name to PFE.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 6004Class IIAug 4, 2025Lack of Assurance of Sterility. |
| Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 600Class IIAug 4, 2025Lack of Assurance of Sterility. |
| Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed bClass IIJul 10, 2025CGMP Deviations; particulates identified during visual inspe |
| Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed bClass IIJul 10, 2025CGMP Deviations; particulates identified during visual inspe |
| DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, FClass IIMay 28, 2025Discoloration; discolored solution from cracked vials |
| Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer LockClass IIMay 20, 2024Lack of Assurance of Sterility-The potential for incomplete |
| Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with LuClass IIMay 20, 2024Lack of Assurance of Sterility-The potential for incomplete |
| 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx OnlyClass IDec 21, 2023Presence of Particulate Matter; identified as glass |
| Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL SClass IDec 21, 2023Presence of Particulate Matter; identified as glass |
| 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous UseClass IDec 21, 2023Presence of Particulate Matter; identified as glass |
| 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injectorClass IOct 2, 2023Presence of Particulate Matter: identified as glass. |
| 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial aClass IOct 2, 2023Presence of Particulate Matter: identified as glass. |
| 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector Class IOct 2, 2023Presence of Particulate Matter: identified as glass. |
| MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned suClass IIIMar 8, 2023Labeling: Incorrect or Missing Lot and/or Exp Date: The car |
| Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) CaseClass IIDec 29, 2022Lack of assurance of sterility: Bags have the potential to l |
| Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton,Class IDec 22, 2022Presence of Particulate Matter: Glass particulate matter det |
| Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. LClass IISep 27, 2022Presence of Particulate Matter: A complaint was received for |
| PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further paClass IAug 22, 2022Presence of particulate matter |
| Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) furtheClass IJul 13, 2022Presence of particulate matter: particulate identified as a |
| Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of PfiClass IIApr 22, 2022CGMP Deviations: Contains N-nitrosoquinapril above the accep |
| Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of PfClass IIApr 22, 2022CGMP Deviations: Contains N-nitrosoquinapril above the accep |
| Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of PfClass IIApr 22, 2022CGMP Deviations: Contains N-nitrosoquinapril above the accep |
| Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-DaClass IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC,Class IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, Class IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, PClass IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-DClass IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: ParkClass IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Class IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis,Class IIMar 21, 2022CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlo |
| 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDClass IINov 30, 2021Lack of sterility assurance: bag has the potential to leak. |
| Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 100Class IIAug 13, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by PfizClass IIAug 13, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NClass IIAug 13, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10Class IIAug 13, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Class IIJun 9, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10Class IIJun 9, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY Class IIJun 9, 2021CGMP Deviations: Presence of the N-nitroso-varenicline impur |
| 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vialClass IMay 3, 2021Labeling: Label Mix-Up: some vials labeled to contain 0.5% B |
| 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19Class IMay 3, 2021Labeling: Label Mix-Up: some vials labeled to contain 0.5% B |
| Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed bClass IIMay 3, 2021Presence of Particulate Matter: particulate matter identifie |