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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

Major and Avet Hydralazine HCl Tablets Recalled for Failed Impurity Testing

Agency Publication Date: November 14, 2024
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Summary

Major Pharmaceuticals and Avet Pharmaceuticals have recalled 25,814 tablets of Hydralazine HCl (25mg) because the medication failed quality tests for impurities and degradation during routine stability checks. Hydralazine is a prescription medication used to treat high blood pressure. While the risk is considered low, the product may not meet safety and quality specifications through its entire shelf life.

Risk

The tablets were found to have levels of impurities or degradation products that exceeded standard safety limits over time. This could potentially affect the medication's quality or expose patients to minor chemical breakdown products.

What You Should Do

  1. This recall affects 100-count cartons of Hydralazine HCl Tablets, USP, 25mg, distributed by Avet Pharmaceuticals Inc. and Major Pharmaceuticals with NDC 0904-6441-61.
  2. Identify your medication by checking for lot numbers T04888 (Exp 11/2024), T04946 (Exp 12/2024), or T04970 (Exp 07/2025) printed on the bottle label or outer carton.
  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: Hydralazine HCl Tablets, USP, 25mg (100-count carton)
Variants: 25mg, Tablet
Lot Numbers:
T04888 (Exp 11/2024)
T04946 (Exp 12/2024)
T04970 (Exp 07/2025)
NDC:
0904-6441-61

Distributed by Avet Pharmaceuticals Inc. and Major Pharmaceuticals.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95700
Status: Resolved
Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold By: Avet Pharmaceuticals Inc.; Major Pharmaceuticals
Manufactured In: United States
Units Affected: 25814 tablets
Distributed To: Nationwide
Agency Last Updated: May 16, 2025

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.