Drug FDA Class III Terminated Failed specifications
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Nov 20, 2024
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 35/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Hazards
Failed Impurities/Degradation Specifications · primary
Affected products (1)
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.
25814 tablets
Code info: Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Affected areas
Nationwide
Timeline
- InitiatedNov 5, 2024
- PublishedNov 20, 2024
- TerminatedSep 16, 2025
- Recall number
- D-0045-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.