Why it was recalled
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Product description
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Lot numbers, UPCs & expiration codes
Lot #: T05693, Exp. Date 03/2026
Where it was sold
Product was distributed nationwide within the United States.
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-0594-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 20, 2025
- FDA report date
- Aug 27, 2025
- Quantity
- 26,628 cartons
- 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-0594-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97449
- Address
- 341 Mason Rd
- Code information
- Lot #: T05693, Exp. Date 03/2026
- Postal code
- 37086-3606
- Report date
- Aug 27, 2025
- Product type
- Drugs
- Recall number
- D-0594-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 26,628 cartons
- Reason for recall
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
- Distribution pattern
- Product was distributed nationwide within the United States.
- Recall initiation date
- Aug 20, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2025