Class II
Ongoing
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
This recall is currently active, issued June 4, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- February 28, 2025
- Posted
- June 4, 2025
- Recall Number
- D-0450-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 84,048 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Distribution
U.S. Nationwide
Lot / Code Info
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
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