Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HydrALAZINE Hydrochloride Tablets Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to an out of specification result obtained during routine...
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 LLC dba Major Pharmaceuticals and Rugby Laboratories directly.
Affected Products
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Quantity: 8,198 units
Why Was This Recalled?
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report