Why it was recalled
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Product description
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Lot numbers, UPCs & expiration codes
Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025.
Where it was sold
Nationwide in the U.S
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-0216-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 22, 2025
- FDA report date
- Feb 12, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0216-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96162
- Address
- 750 Corporate Dr
- Code information
- Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025.
- Postal code
- 07430-2009
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0216-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Reason for recall
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
- Distribution pattern
- Nationwide in the U.S
- Recall initiation date
- Jan 22, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2025