Class II
Carvedilol Tablets, USP, 25 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: 68462-165-05
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Recall number
- D-0588-2025
- Report date
- August 20, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Generic names
- CARVEDILOL
- Brand names
- CARVEDILOL
- Product NDCs
- 68462-162, 68462-163, 68462-164, 68462-165
Code and lot information
Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026
Distribution
Nationwide within the USA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.