Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Hydralazine Hydrochloride Tablets Recalled for Impurities

Agency Publication Date: March 14, 2022

Summary

The Harvard Drug Group is recalling hydrALAZINE HCl (hydralazine hydrochloride) tablets (10 mg strength) under the Major Pharmaceuticals brand. This recall involves 5,953 cartons because routine testing found that the medication did not meet impurity and degradation specifications. No injuries or illnesses have been reported in connection with this recall. These prescription tablets are used to treat high blood pressure and were distributed in cartons of 100 tablets containing blister packs.

Risk

Testing revealed levels of impurities or degraded components that exceed safety standards, which could potentially impact the medication's quality or safety. No incidents or injuries have been reported to date.

What You Should Do

The recalled products are Major Pharmaceuticals hydrALAZINE HCl Tablets, USP, 10 mg, sold in 100-tablet cartons (10x10 blister packs) with NDC 0904-6440-61.
Check your medication packaging for lot numbers T03755 or T03756 with an expiration date of 03/2023.
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 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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 (10 mg, 100-tablet carton)by MAJOR PHARMACEUTICALS

Variants: 10 mg, Tablets, 10x10 blister packs

Lot Numbers:

T03755 (Exp 03/2023)

T03756 (Exp 03/2023)

NDC:

0904-6440-61

Distributed by Major Pharmaceuticals, Livonia, MI 48152.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89663

Status: Resolved

Manufacturer: The Harvard Drug Group

Sold By: MAJOR PHARMACEUTICALS; Pharmacies

Manufactured In: United States

Units Affected: 5,953 cartons

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 · 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.

Summary

What You Should Do

The recalled products are Major Pharmaceuticals hydrALAZINE HCl Tablets, USP, 10 mg, sold in 100-tablet cartons (10x10 blister packs) with NDC 0904-6440-61.

Check your medication packaging for lot numbers T03755 or T03756 with an expiration date of 03/2023.

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 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.