Class II
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
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Recall number
- D-0450-2025
- Report date
- June 4, 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, 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
Distribution
U.S. Nationwide
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.