Class IIOngoing

Carvedilol Tablets USP recall

FDA recall D-0594-2025 · initiated Aug 20, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Details

Product: 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
Recalling company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Product was distributed nationwide within the United States.
Initiated: Aug 20, 2025
FDA report date: Aug 27, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0594-2025 ↗

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