Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Quinapril and Hydrochlorothiazide Tablets Recalled for Impurity Levels

Agency Publication Date: October 26, 2022
Share:
Sign in to monitor this recall

Summary

Aurobindo Pharma USA Inc. is recalling 9,504 bottles of Quinapril and Hydrochlorothiazide Tablets, USP (20mg/12.5mg), a medication used to treat high blood pressure. The recall was issued because testing detected an impurity known as N-Nitroso-quinapril at levels exceeding the acceptable daily intake limit set by the FDA. No illnesses or injuries related to this issue have been reported to date. Patients currently taking this medication should contact their healthcare provider or pharmacist to discuss alternative treatments or concerns.

Risk

Long-term exposure to N-Nitroso-quinapril at levels higher than the acceptable daily limit may increase the risk of cancer over time. There are currently no reported incidents or injuries linked to these specific batches of medication.

What You Should Do

  1. This recall involves 90-count bottles of Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, with NDC code 65862-162-90.
  2. Identify if your product is affected by checking the lot number and expiration date printed on the bottle label. The recalled lots are QE2021005-A and QE2021010-A, both with an expiration date of 01/2023.
  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 Aurobindo Pharma USA Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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: Quinapril and Hydrochlorothiazide Tablets, USP (90 Tablets bottle)
Variants: 20mg/12.5mg, Tablet
Lot Numbers:
QE2021005-A (Exp 01/2023)
QE2021010-A (Exp 01/2023)
NDC:
65862-162-90

Quantity: 9504 bottles distributed.

Product Images

Product label, Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90 Tablets

Product label, Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90 Tablets

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90949
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: Pharmacies; Hospitals; Healthcare Providers
Manufactured In: India, United States
Units Affected: 9504 bottles
Distributed To: Nationwide
Agency Last Updated: October 28, 2022

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 FDA Press Release 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.