Class II
Ongoing
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
This recall is currently active, issued August 20, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- August 7, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0579-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,800 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Distribution
Nationwide in the USA
Lot / Code Info
Lot#:19243104, Expires: 7/31/2026.
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