FDAHealthAugust 6, 2025
Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur,
⚠️ CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 6, 2025
Nationwide within the USA
What's affected?
- Product
- Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
- Brand
- CARVEDILOL
- UPC
- 0368462162019
- Lot code
- 17241257
Additional details
Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 17, 496 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.