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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Amneal Pharmaceuticals, Inc.: Benazepril HCl Tablets Recalled Due to Mislabeling with Promethazine HCl

Agency Publication Date: October 9, 2019
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Summary

Amneal Pharmaceuticals is recalling 9,720 bottles of Benazepril HCl Tablets, USP 40 mg, a medication used to treat high blood pressure. The recall was initiated because a different medication, Promethazine HCl (used for allergies and motion sickness), was found inside a bottle of Benazepril. Taking the wrong medication can lead to serious health issues, as the drugs have entirely different uses and side effects. This recall affects 100-count bottles distributed to 13 major distributors across the United States.

Risk

A patient may inadvertently ingest Promethazine HCl instead of their prescribed blood pressure medication, which can cause unexpected sedation, dizziness, or interactions with other drugs. Conversely, failing to take the intended Benazepril could result in uncontrolled high blood pressure.

What You Should Do

  1. Check your medication bottle for Benazepril HCl Tablets, USP 40 mg (100-count) with NDC 65162-754-10.
  2. Identify if your bottle is from Lot # BB02619A with an expiration date of 04/2021.
  3. If your bottle matches this lot and description, contact your healthcare provider or pharmacist immediately for guidance and to obtain a correct replacement.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund.
  5. Contact Amneal Pharmaceuticals, Inc. at their Brookhaven, NY location for further instructions regarding this voluntary recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall remedy for consumers.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Benazepril HCl Tablets, USP 40 mg (100 count bottles)
Model:
NDC 65162-754-10
Recall #: D-0134-2020
Lot Numbers:
BB02619A (Exp 04/2021)
Date Ranges: 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83915
Status: Resolved
Manufacturer: Amneal Pharmaceuticals, Inc.
Sold By: 13 major distributors
Manufactured In: United States
Units Affected: 9,720 100 count bottles
Distributed To: Nationwide

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.