Hydralazine HCl Tablets — Class III drug recall D-0045-2025
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2024-11-20, distributed nationwide. Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
| Recall number | D-0045-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2024-11-05 |
| Classified | 2024-11-14 |
| Reported by FDA | 2024-11-20 |
| Terminated | 2025-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 25,814 tablets |
| Reason classes | specification failure |
| NDC | 00904-6441-61 |
| Lot numbers | T04888, T04946, T04970 |
| Expiration dates | 2024-11, 2024-12, 2025-07 |
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 for recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0045-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.