Recalls / Class II
Class IID-0577-2025
Product
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Active ingredient
- Carvedilol
- Route
- Oral
- NDCs
- 68462-162, 68462-163, 68462-164, 68462-165
- FDA application
- ANDA078251
- Affected lot / code info
- Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Why it was recalled
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 44,328 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-07
- FDA classified
- 2025-08-12
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0577-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.