Class II
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
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-0594-2025
- Report date
- August 27, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Generic names
- CARVEDILOL
- Brand names
- CARVEDILOL
- Product NDCs
- 0904-7305, 0904-7306, 0904-7307, 0904-7308
Code and lot information
Lot #: T05693, Exp. Date 03/2026
Distribution
Product was distributed nationwide within the United States.
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.