Drug recall D-0579-2025
Product
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
Reason for recall
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Lots and codes
Lot#:19243104, Expires: 7/31/2026.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 4,800 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 7, 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