Drug recall D-0588-2025
Product
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
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
Lots and codes
Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 14,976 bottles
- Distribution
- Nationwide within the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 6, 2025
Related products
- Carvedilol – drug information
- NDC 68462-164 Carvedilol · Carvedilol 12.5 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-163 Carvedilol · Carvedilol 6.25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-165 Carvedilol · Carvedilol 25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-162 Carvedilol · Carvedilol 3.125 mg/1 · Glenmark Pharmaceuticals Inc., USA