Drug Recall: 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
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · November 5, 2024
Reason for Recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Product Description
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.
Distribution
Nationwide in the US.
States Affected
NATIONWIDE
Quantity Affected
25814 tablets
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0045-2025
Status: terminated
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.