Drug recall D-0448-2025
Product
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Reason for recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots and codes
[100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843, 19235039, Exp Nov-25; Lots 19240280, 19240296, Dec-25
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 28, 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