DrugAug 6, 2025
Bicillin L-A recall — FDA D-0544-2025
CGMP Deviations; particulates identified during visual inspection
Class IIFDA: OngoingPfizer Inc.
Recall history in this database
Classification mix: Class II: 48, Class III: 29, Class I: 15.
DrugAug 6, 2025
Bicillin L-A recall — FDA D-0545-2025
CGMP Deviations; particulates identified during visual inspection
Class IIFDA: OngoingPfizer Inc.
DrugJul 2, 2025
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of recall — FDA D-0489-2025
Discoloration; discolored solution from cracked vials
Class IIFDA: OngoingPfizer Inc.
DrugJul 3, 2024
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject recall — FDA D-0565-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class IIFDA: OngoingPfizer Inc.
DrugJul 3, 2024
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile recall — FDA D-0564-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class IIFDA: OngoingPfizer Inc.
DrugJan 24, 2024
Pfizer 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit recall — FDA D-0233-2024
Presence of Particulate Matter; identified as glass
Class IFDA: OngoingPfizer Inc.
DrugJan 24, 2024
SODIUM BICARBONATE 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) recall — FDA D-0234-2024
Presence of Particulate Matter; identified as glass
Class IFDA: OngoingPfizer Inc.
DrugJan 24, 2024
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of recall — FDA D-0235-2024
Presence of Particulate Matter; identified as glass
Class IFDA: OngoingPfizer Inc.
DrugNov 15, 2023
LIDOCAINE HYDROCHLORIDE 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT recall — FDA D-0102-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugNov 15, 2023
Pfizer 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit recall — FDA D-0100-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugNov 15, 2023
LIDOCAINE HYDROCHLORIDE 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT recall — FDA D-0101-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugApr 19, 2023
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle recall — FDA D-0532-2023
Labeling: 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 February 2025.
Class IIIFDA: OngoingPfizer Inc.
DrugFeb 1, 2023
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop recall — FDA D-0184-2023
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class IFDA: TerminatedPfizer Inc.
DrugJan 11, 2023
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride recall — FDA D-0097-2023
Lack of assurance of sterility: Bags have the potential to leak.
Class IIFDA: CompletedPfizer Inc.
DrugOct 12, 2022
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial recall — FDA D-0003-2023
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class IIFDA: TerminatedPfizer Inc.
DrugSep 21, 2022
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL) recall — FDA D-1540-2022
Presence of particulate matter
Class IFDA: TerminatedPfizer Inc.
DrugAug 3, 2022
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL) recall — FDA D-1301-2022
Presence of particulate matter: particulate identified as a beetle.
Class IFDA: TerminatedPfizer Inc.
DrugSep 29, 2021
Pfizer Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets recall — FDA D-0811-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class IIFDA: OngoingPfizer Inc.
DrugSep 29, 2021
Pfizer Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets recall — FDA D-0808-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class IIFDA: OngoingPfizer Inc.
DrugSep 29, 2021
Chantix (varenicline) tablets 1 mg, 56 Tablets recall — FDA D-0810-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class IIFDA: OngoingPfizer Inc.
DrugAug 11, 2021
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing recall — FDA D-0700-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class IIFDA: OngoingPfizer Inc.
DrugJun 9, 2021
BUPIVACAINE HYDROCHLORIDE 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL recall — FDA D-0626-2021
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1%…
Class IFDA: TerminatedPFIZER, Inc.
DrugJun 9, 2021
LIDOCAINE HYDROCHLORIDE 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL recall — FDA D-0627-2021
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1%…
Class IFDA: TerminatedPFIZER, Inc.
DrugMay 26, 2021
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton recall — FDA D-0384-2021
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class IIFDA: TerminatedPfizer Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Pfizer Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.