Pfizer Inc.
Complete recall history across all FDA and CPSC categories — 114 total recalls
Recall Summary
Pfizer Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (111)
FDA drug safety enforcement actions by Pfizer Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 10, 2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... | CGMP Deviations; particulates identified during visual inspection | Class II |
| Jul 10, 2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... | CGMP Deviations; particulates identified during visual inspection | Class II |
| May 28, 2025 | DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose V... | Discoloration; discolored solution from cracked vials | Class II |
| May 20, 2024 | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Class II |
| May 20, 2024 | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Class II |
| Dec 21, 2023 | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... | Presence of Particulate Matter; identified as glass | Class I |
| Dec 21, 2023 | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... | Presence of Particulate Matter; identified as glass | Class I |
| Dec 21, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... | Presence of Particulate Matter; identified as glass | Class I |
| Oct 2, 2023 | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... | Presence of Particulate Matter: identified as glass. | Class I |
| Oct 2, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... | Presence of Particulate Matter: identified as glass. | Class I |
| Oct 2, 2023 | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... | Presence of Particulate Matter: identified as glass. | Class I |
| Mar 8, 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle la... | Class III |
| Dec 29, 2022 | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... | Lack of assurance of sterility: Bags have the potential to leak. | Class II |
| Dec 22, 2022 | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Class I |
| Sep 27, 2022 | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... | Presence of Particulate Matter: A complaint was received for the presence of ... | Class II |
| Aug 22, 2022 | PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass... | Presence of particulate matter | Class I |
| Jul 13, 2022 | Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... | Presence of particulate matter: particulate identified as a beetle. | Class I |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablet... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tabl... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablet... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only,... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tab... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tab... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Mar 21, 2022 | quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, ... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impuri... | Class II |
| Nov 30, 2021 | 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... | Lack of sterility assurance: bag has the potential to leak. | Class II |
| Aug 13, 2021 | Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s a... | Class II |
| Aug 13, 2021 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s a... | Class II |
| Aug 13, 2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 t... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s a... | Class II |
| Aug 13, 2021 | Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s a... | Class II |
| Jun 9, 2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs ac... | Class II |
| Jun 9, 2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs ac... | Class II |
| Jun 9, 2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s a... | Class II |
| May 3, 2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... | Presence of Particulate Matter: particulate matter identified as an insect in... | Class II |
| Jul 20, 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... | Lack of Assurance of Sterility; potential loose metal overseal crimp defects. | Class II |
| May 29, 2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... | Presence of Particulate Matter: particulate matter identified after reconstit... | Class II |
| May 27, 2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... | Failed Dissolution Specifications | Class III |
| Feb 27, 2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vial... | Class II |
| Feb 5, 2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-c... | Defective Container: products potentially could have been packaged in defecti... | Class II |
| Feb 5, 2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-c... | Defective Container: products potentially could have been packaged in defecti... | Class II |
| Feb 3, 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... | Defective Container: confirmed customer reports for vials with loose metal ov... | Class II |
| Nov 27, 2019 | 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... | Labeling: Incorrect or Missing Lot and/or expiration date. | Class II |
| Oct 2, 2019 | 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ... | Lack of Assurance of Sterility: Bag has the potential to leak. | Class II |
| Sep 12, 2019 | ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the p... | Class III |
| Sep 12, 2019 | Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the p... | Class III |
| Sep 6, 2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... | Lack of Assurance of Sterility | Class II |
| Aug 14, 2019 | RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta... | Microbial Contamination of Non-Sterile Products: contamination with Burkholde... | Class II |
Device Recalls (3)
FDA medical device enforcement actions by Pfizer Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2018 | Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 ... | The firm received complaints of the wrap coming apart and leaking granular ma... | Class II |
| Oct 2, 2018 | Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 05733013... | The firm received complaints of the wrap coming apart and leaking granular ma... | Class II |
| Oct 2, 2018 | Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Produ... | The firm received complaints of the wrap coming apart and leaking granular ma... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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