PFIZER INC

41 FDA enforcement actions

41 Total Recalls

11 Class I

29 Class II

1 Class III

Firm Details

Product Types: drug
States: NY, IL

All Recalls

Class II: Risk 08/04/2025 drug

Lack of Assurance of Sterility.
Class II: Risk 08/04/2025 drug

Lack of Assurance of Sterility.
Class II: Risk 07/10/2025 drug

CGMP Deviations; particulates identified during visual inspection
Class II: Risk 07/10/2025 drug

CGMP Deviations; particulates identified during visual inspection
Class II: Risk 05/28/2025 drug

Discoloration; discolored solution from cracked vials
Class II: Risk 05/20/2024 drug

Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II: Risk 05/20/2024 drug

Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class I: Dangerous 12/21/2023 drug

Presence of Particulate Matter; identified as glass
Class I: Dangerous 12/21/2023 drug

Presence of Particulate Matter; identified as glass
Class I: Dangerous 12/21/2023 drug

Presence of Particulate Matter; identified as glass
Class I: Dangerous 10/02/2023 drug

Presence of Particulate Matter: identified as glass.
Class I: Dangerous 10/02/2023 drug

Presence of Particulate Matter: identified as glass.
Class I: Dangerous 10/02/2023 drug

Presence of Particulate Matter: identified as glass.
Class III: Low Risk 03/08/2023 drug

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 II: Risk 12/29/2022 drug

Lack of assurance of sterility: Bags have the potential to leak.
Class I: Dangerous 12/22/2022 drug

Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class II: Risk 09/27/2022 drug

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class I: Dangerous 08/22/2022 drug

Presence of particulate matter
Class I: Dangerous 07/13/2022 drug

Presence of particulate matter: particulate identified as a beetle.
Class II: Risk 04/22/2022 drug

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II: Risk 04/22/2022 drug

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II: Risk 04/22/2022 drug

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 03/21/2022 drug

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II: Risk 11/30/2021 drug

Lack of sterility assurance: bag has the potential to leak.
Class II: Risk 08/13/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II: Risk 08/13/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II: Risk 08/13/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II: Risk 08/13/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II: Risk 06/09/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II: Risk 06/09/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II: Risk 06/09/2021 drug

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class I: Dangerous 05/03/2021 drug

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% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I: Dangerous 05/03/2021 drug

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% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class II: Risk 05/03/2021 drug

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.