FDA Drug recall D-0045-2025
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, D…
- FDA Drug
- Class III
- terminated
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class III recall of Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, D… by The Harvard Drug Group, citing failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0045-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-11-05 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Identifiers
| code_info | Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0045-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.