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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

Amneal Phenoxybenzamine Hydrochloride Capsules Recalled for Unknown Impurity

Agency Publication Date: February 8, 2024
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Summary

Amneal Pharmaceuticals has voluntarily recalled 858 bottles of Phenoxybenzamine Hydrochloride Capsules (10mg), a prescription medication used to manage certain blood pressure conditions. The recall was initiated because testing detected an unknown impurity that does not meet required safety and degradation specifications. No injuries or adverse events have been reported in connection with this recall.

Risk

The presence of unknown impurities in medication can lead to unpredictable side effects or may reduce the effectiveness of the drug in managing blood pressure. While no specific incidents have been reported, the medication no longer meets the strict quality standards required for safe use.

What You Should Do

  1. The recalled products are 100-count bottles of Phenoxybenzamine Hydrochloride Capsules, USP 10mg, identified by NDC 60219-1502-01.
  2. Check your medication bottle for lot numbers AM221153 (Expiration Date: 06/30/2024) or AM230497 (Expiration Date: 02/29/2025).
  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) if you have additional questions regarding this recall.

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: Phenoxybenzamine Hydrochloride Capsules, USP 10mg (100-count bottle)
Variants: 10mg, Capsule
Lot Numbers:
AM221153 (Exp. 06/30/2024)
AM230497 (Exp. 02/29/2025)
NDC:
60219-1502-01

Rx only; Manufactured by Amneal Pharmaceuticals Pvt. Ltd in India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93813
Status: Resolved
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 858 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.