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.

Recall Number: D-0045-2025

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Classification: Class III

Status: Terminated

Report Date: 20241120

Initiation Date: 20241105

Termination Date: 20250916

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

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.