Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

hydrALAZINE HCl Tablets Recalled by The Harvard Drug Group Due to Failed Impurities/Degradation Specifications: Out of specification result obtained...

Date: February 24, 2022
Company: The Harvard Drug Group
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group directly.

Affected Products

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

Quantity: 5,953 cartons

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group

The Harvard Drug Group has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report