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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Accupril Tablets Recalled for Potential Carcinogen Contamination

Agency Publication Date: May 17, 2022
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Summary

Pfizer Inc. is voluntarily recalling approximately 20,729 bottles of Accupril (quinapril HCl) tablets used to treat high blood pressure. This recall affects the 10 mg, 20 mg, and 40 mg strengths of the medication sold in 90-count bottles. The tablets were found to contain levels of N-nitrosoquinapril, a probable carcinogen, above acceptable safety limits. No injuries or illnesses have been reported to date, and the company is taking this action as a precaution.

Risk

The tablets may contain N-nitrosoquinapril, which is a type of nitrosamine. These impurities are classified as probable human carcinogens, meaning that long-term exposure to levels above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. The recalled products are 90-count bottles of Accupril (quinapril HCl) tablets in 10 mg, 20 mg, and 40 mg strengths distributed by Pfizer's Parke-Davis Division.
  2. Check your medication bottle for NDC numbers 0071-0530-23, 0071-0532-23, or 0071-0535-23 and lot numbers DR9639, DX8682, DG1188, DX6031, or CK6260 with expiration dates ranging from March 2022 to March 2023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Accupril (Quinapril HCl Tablets) 10 mg (90 Tablets)by Accupril
Variants: 10 mg, Tablet
Lot Numbers:
DR9639 (Exp. MAR 31 2023)
NDC:
0071-0530-23

Recall #: D-0872-2022

Product: Accupril (Quinapril HCl Tablets) 20 mg (90 Tablets)by Accupril
Variants: 20 mg, Tablet
Lot Numbers:
DX8682 (Exp. MAR 31 2023)
DG1188 (Exp. MAR 31 2022)
NDC:
0071-0532-23

Recall #: D-0873-2022

Product: Accupril (Quinapril HCl Tablets) 40 mg (90 Tablets)by Accupril
Variants: 40 mg, Tablet
Lot Numbers:
DX6031 (Exp. MAR 31 2023)
CK6260 (Exp. MAY 31 2022)
NDC:
0071-0535-23

Recall #: D-0874-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90064
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3 products (2079 bottles; 10,304 bottles; 8346 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.