Why it was recalled
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Product description
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Lot numbers, UPCs & expiration codes
Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
Where it was sold
U.S. Nationwide
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-0450-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 28, 2025
- FDA report date
- Jun 4, 2025
- Quantity
- 84,048 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0450-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96861
- Address
- 750 Corporate Dr
- Code information
- Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
- Postal code
- 07430-2009
- Report date
- Jun 4, 2025
- Product type
- Drugs
- Recall number
- D-0450-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 84,048 bottles
- Reason for recall
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 28, 2025
- Initial firm notification
- Letter
- Center classification date
- May 28, 2025