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.
Class III · Terminated
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
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Affected lots / codes — check yours against thisLot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN
- Classification
- Class III (unlikely to cause harm)
- Status
- Terminated
- Quantity
- 25814 tablets
- Distribution
- Nationwide in the US.
- Recall initiated
- November 5, 2024
- Classified
- November 14, 2024
- Terminated
- September 16, 2025
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0045-2025%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0045-2025%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
See every recall for this brand: Is The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled? →
Check this brand across all 8 databases →