Pfizer Inc. Provisional
FDA Flags (40)
Class II RecallAug 2025
PFIZER INC
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 600
Classification: Class II
Class II RecallAug 2025
PFIZER INC
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 6004
Classification: Class II
Class II RecallAug 2025
Pfizer
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, N
Classification: Class II
Class II RecallAug 2025
Pfizer Inc.
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed b
Classification: Class II
Class II RecallAug 2025
Pfizer Inc.
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed b
Classification: Class II
Class II RecallJul 2025
Pfizer Inc.
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, F
Classification: Class II
Class II RecallJul 2024
Pfizer Inc.
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Lu
Classification: Class II
Class II RecallJul 2024
Pfizer Inc.
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock
Classification: Class II
Class I RecallJan 2024
PFIZER
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc
Classification: Class I
Class I RecallJan 2024
Pfizer Inc.
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use
Classification: Class I
Class I RecallJan 2024
Pfizer Inc.
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only
Classification: Class I
Class I RecallJan 2024
Pfizer Inc.
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL S
Classification: Class I
Class I RecallNov 2023
Pfizer Inc.
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector
Classification: Class I
Class I RecallNov 2023
Pfizer Inc.
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a
Classification: Class I
Class I RecallNov 2023
Pfizer Inc.
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector
Classification: Class I
Class III RecallApr 2023
Pfizer Inc.
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned su
Classification: Class III
Class I RecallFeb 2023
Pfizer Inc.
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton,
Classification: Class I
Class II RecallJan 2023
Pfizer Inc.
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) Case
Classification: Class II
Class II RecallOct 2022
Pfizer Inc.
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. L
Classification: Class II
Class I RecallSep 2022
Pfizer Inc.
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further pa
Classification: Class I
Class I RecallAug 2022
Pfizer Inc.
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) furthe
Classification: Class I
Class II RecallMay 2022
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfi
Classification: Class II
Class II RecallMay 2022
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pf
Classification: Class II
Class II RecallMay 2022
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pf
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, P
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC,
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis,
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Park
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack,
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-D
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-
Classification: Class II
Class II RecallApr 2022
Pfizer Inc.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Da
Classification: Class II
Class II RecallDec 2021
Pfizer Inc.
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, ND
Classification: Class II
Class II RecallSep 2021
Pfizer Inc.
Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10
Classification: Class II
Class II RecallSep 2021
Pfizer Inc.
Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfiz
Classification: Class II
Class II RecallSep 2021
Pfizer Inc.
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, N
Classification: Class II
Class II RecallSep 2021
Pfizer Inc.
Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 100
Classification: Class II
Class II RecallAug 2021
Pfizer Inc.
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY
Classification: Class II
Class II RecallAug 2021
Pfizer Inc.
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10
Classification: Class II
Class II RecallAug 2021
Pfizer Inc.
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets),
Classification: Class II