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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

Phenoxybenzamine Hydrochloride Capsules Recalled for Impurity Specifications

Agency Publication Date: November 15, 2022
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Summary

Par Pharmaceutical is recalling 218 bottles of Phenoxybenzamine Hydrochloride (Phenoxybenzamine) 10mg capsules because testing revealed the product failed to meet impurity and degradation specifications. This prescription medication is used to treat symptoms of high blood pressure and sweating related to certain adrenal gland tumors. No injuries or adverse events have been reported in connection with this recall.

Risk

The medication may contain impurities or breakdown products that exceed safe regulatory standards. This could potentially reduce the effectiveness of the treatment or cause unexpected side effects for patients.

What You Should Do

  1. The recalled product is Phenoxybenzamine Hydrochloride Capsules, USP 10mg, sold in 100-count bottles (NDC 49884-038-01) from lot 15429401 with an expiration date of August 2023.
  2. 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 Par Pharmaceutical for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

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 bottles)
Variants: 10mg, 100-count bottle
Lot Numbers:
15429401 (Exp 08/2023)
NDC:
49884-038-01

Quantity affected: 218 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91110
Status: Resolved
Manufacturer: Par Formulations Private Limited
Sold By: pharmacies
Manufactured In: India
Units Affected: 218 bottles/100 capsules per bottle
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.