Recalls / Class II
Class IID-0450-2025
Product
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
- 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, 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
Why it was recalled
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
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
- 84,048 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-02-28
- FDA classified
- 2025-05-28
- Posted by FDA
- 2025-06-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0450-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.