Recalls / Class III
Class IIID-0045-2025
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.
- Affected lot / code info
- Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 25814 tablets
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2024-11-05
- FDA classified
- 2024-11-14
- Posted by FDA
- 2024-11-20
- Terminated
- 2025-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0045-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.