The Recall Desk

Manufacturer

Pfizer Inc.

123 recalls in our database name Pfizer Inc. as the manufacturing or recalling firm.

What the numbers show

Total
123
Critical
6
Severe
28
Most recent
2025-08-27

Of the 123 recalls from Pfizer Inc. we have scored against our rubric, 6 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (23%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 123

  • HighFDA (Drugs)·D-0754-2022·2022-04-13

    Pfizer recalls Accuretic blood pressure tablets for impurities exceeding acceptable limits

    Pfizer is recalling 53 bottles of Accuretic blood pressure tablets nationwide due to manufacturing impurities that exceed FDA acceptable daily intake limits. The affected lot is FG5379, expiring August 2024.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0757-2022·2022-04-13

    Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity

    Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0756-2022·2022-04-13

    Accuretic Tablets Recalled Due to Excess N-Nitroso Impurity

    Pfizer is recalling Accuretic (quinapril/hydrochlorothiazide) tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. The impurity resulted from a manufacturing deviation.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0760-2022·2022-04-13

    Pfizer Recalls Quinapril/Hydrochlorothiazide Tablets for N-Nitroso Impurities

    Pfizer is recalling 1,104 bottles of quinapril/hydrochlorothiazide tablets due to nitrosamine impurities above acceptable limits. The affected lot (DP3414) was distributed nationwide.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2022·2022-04-13

    Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity

    Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2022·2021-12-08

    Pfizer 5% Dextrose Injection Recalled for Potential Bag Leakage

    Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0808-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for Nitroso Impurity

    Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.

    Product
    Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2021·2021-09-29

    Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity

    Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0811-2021·2021-09-29

    Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits

    Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.

    Product
    Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity

    Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity

    Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0701-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit

    Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0627-2021·2021-06-09

    Pfizer Lidocaine and Bupivacaine Injection Label Mix-Up Recall

    Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0626-2021·2021-06-09

    Bupivacaine and Lidocaine Injection Vials Recalled for Label Mix-Up

    Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2021·2021-05-26

    Pfizer Recalls Sterile Water Vials Due to Insect Particulate Matter

    Pfizer is recalling 49,525 vials of Sterile Water for Injection because an insect was found in one vial. The product is distributed nationwide.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1342-2020·2020-07-01

    Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications

    Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.

    Product
    Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1306-2020·2020-06-17

    Pfizer Recalls Unasyn Injection Due to Particulate Matter

    Pfizer is recalling specific lots of Unasyn (ampicillin sodium and sulbactam sodium) for injection because particulate matter was identified after reconstitution.

    Product
    UNASYN — UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0995-2020·2020-03-11

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection due to reports of loose metal ferrule crimps that compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0835-2020·2020-02-19

    Pfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects

    Pfizer is recalling 38,676 trays of Fentanyl Citrate Injection vials because loose metal overseal crimps may compromise sterility.

    Product
    Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2020·2020-02-19

    Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals

    Pfizer is recalling 128 bottles of Caduet (amlodipine and atorvastatin) because defective bottle rims may have caused inadequate foil sealing, potentially compromising moisture protection.

    Product
    CADUET — CADUET (AMLODIPINE AND ATORVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2020·2020-02-19

    Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals

    Pfizer is recalling 141 bottles of Caduet tablets because defective bottle rims may have allowed moisture to enter, potentially compromising the medication.

    Product
    CADUET — CADUET (AMLODIPINE AND ATORVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2020·2019-10-16

    Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns

    Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.

    Product
    LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Pfizer

American multinational pharmaceutical and biotechnology corporation

Country
United States
Founded
1849

Official website

Source: Wikidata (Q206921), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.