Recalls / Class II
Class IID-0578-2025
Product
Carvedilol Tablets, USP, 12.5 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 68462-164-05
- 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#:19243202, Exp: 7/31/2026.
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
- 6,432 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-0578-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.