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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

Major Pharmaceuticals HydrALAZINE Hydrochloride Recalled for Impurities

Agency Publication Date: February 13, 2024
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Summary

The Harvard Drug Group LLC (doing business as Major Pharmaceuticals) has recalled 8,198 units of HydrALAZINE Hydrochloride (hydralazine) 10mg tablets. This recall was initiated after routine testing found that the medication did not meet required specifications for impurities. Consumers who have this medication should check their packaging for specific lot numbers and contact their doctor or pharmacist.

Risk

There is a remote possibility that using this product with higher-than-expected impurities could cause temporary or reversible adverse health consequences.

What You Should Do

  1. This recall affects HydrALAZINE Hydrochloride Tablets, USP 10mg, sold in 100-count blister cards (NDC 0904-6440-61) with lot number T04680 and an expiration date of 6/2024.
  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 The Harvard Drug Group LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for 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: HydrALAZINE Hydrochloride Tablets, USP 10mg (100-count blister cards)
Variants: 10 mg, Tablet
Lot Numbers:
T04680 (Exp. 6/2024)
NDC:
0904-6440-61

Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ; Distributed by Major Pharmaceuticals Livonia MI.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93929
Status: Resolved
Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold By: Authorized distributors; Retail pharmacies
Manufactured In: United States
Units Affected: 8,198 units
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.