Recalls / Class II
Class IID-0594-2025
Product
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Active ingredient
- Carvedilol
- Route
- Oral
- NDCs
- 0904-7305, 0904-7306, 0904-7307, 0904-7308
- FDA application
- ANDA078251
- Affected lot / code info
- Lot #: T05693, Exp. Date 03/2026
Why it was recalled
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 26,628 cartons
- Distribution pattern
- Product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2025-08-20
- FDA classified
- 2025-08-21
- Posted by FDA
- 2025-08-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0594-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.