Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0045-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 5, 2024
- FDA report date
- Nov 20, 2024
- Quantity
- 25814 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0045-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 95700
- Address
- 341 Mason Rd
- Code information
- Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
- Postal code
- 37086-3606
- Report date
- Nov 20, 2024
- Product type
- Drugs
- Recall number
- D-0045-2025
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 25814 tablets
- Termination date
- Sep 16, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Nov 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2024