Class II
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Recall number
- D-0577-2025
- 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#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Distribution
Nationwide in 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.