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.

76–100 of 123

  • SevereFDA (Drugs)·D-0151-2018·2018-01-10

    Pfizer Recalls Zoloft Tablets Due to Weight Variations

    Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.

    Product
    Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2018·2018-01-10

    Pfizer Recalls Diphenoxylate and Atropine Tablets Due to Potency Variations

    Pfizer is recalling specific lots of diphenoxylate hydrochloride and atropine sulfate tablets because weight variations caused some tablets to be sub-potent or super-potent.

    Product
    DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0123-2018·2017-12-27

    Pfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter

    Pfizer Inc. is recalling 102,500 vials of Vancomycin Hydrochloride for Injection due to the presence of glass particulate matter.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0001-2018·2017-10-11

    Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations

    Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.

    Product
    Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1177-2017·2017-10-04

    Pfizer Recalls Sterile Water for Injection Vials Due to Cracked Glass

    Pfizer is recalling 18,725 vials of Sterile Water for Injection due to cracked or chipped glass at the neck, which poses a non-sterility risk.

    Product
    Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2017·2017-09-27

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1168-2017·2017-09-27

    Pfizer Recalls Levophed Injection Due to Sterility Assurance Concerns

    Pfizer is recalling specific lots of Levophed (norepinephrine bitartrate) injection because a damaged sterilizing filter may have compromised sterility.

    Product
    LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1164-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure

    Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1163-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures

    Pfizer is recalling 14,712 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0609-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0608-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension due to failed dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2017·2017-03-22

    Pfizer Recalls PROTONIX IV Vials for Subpotent Potency

    Pfizer is recalling 582,165 vials of PROTONIX IV (pantoprazole sodium) because the drug failed potency testing at the 6-month stability time point.

    Product
    PROTONIX — PROTONIX (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0424-2017·2017-01-18

    Pfizer Recalls Cytotec Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 1,706 cartons of Cytotec (misoprostol) tablets nationwide because the product failed impurity and degradation specifications.

    Product
    CYTOTEC — CYTOTEC (MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0800-2016·2016-04-06

    Pfizer Recalls Robitussin Peak Cold Liquid Due to Labeling Error

    Pfizer is recalling 63,636 bottles of Robitussin Peak Cold Liquid nationwide due to a label mix-up. Consumers should stop using the product and return it to the point of purchase.

    Product
    Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2016·2016-02-10

    Pfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells

    Pfizer is recalling specific lots of Lyrica (pregabalin) 50 mg capsules due to the potential presence of deformed or damaged capsules.

    Product
    LYRICA — LYRICA (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2016·2015-12-16

    Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification

    Pfizer is recalling Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications. The recall covers specific lots distributed nationwide.

    Product
    NORPACE CR — NORPACE CR (DISOPYRAMIDE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2016·2015-11-04

    Pfizer Recalls Subpotent Xanax Alprazolam Tablets Nationwide

    Pfizer is voluntarily recalling 21,120 bottles of Xanax (alprazolam) 0.25 mg tablets because the medication contains less active ingredient than labeled.

    Product
    XANAX — XANAX (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0292-2015·2014-12-17

    Pfizer Recalls Tikosyn Capsules Due to Potential Cracks or Breakage

    Pfizer is recalling Tikosyn (dofetilide) capsules because they may be cracked or broken. The recall affects 31,569 bottles shipped to 4,447 direct accounts.

    Product
    TIKOSYN — TIKOSYN (DOFETILIDE)
    Category
    Drug
    Distribution
    0 states

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.