The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Bru
Recalled November 20, 2024 · FDA recall D-0045-2025 · The Harvard Drug Group LLC
Hazard
Failed Impurities/Degradation Specifications; during routine stability testing for impurities. · FDA Class III
Units
25814 tablets
Sold at
Nationwide in the US.
Description
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Product
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →