Class IITerminated

Carvedilol 25 mg Tablet recall

FDA recall D-0217-2025 · initiated Jan 24, 2025

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

Why it was recalled

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

Details

Product: Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Recalling company: RemedyRepack Inc.
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: FL
Initiated: Jan 24, 2025
FDA report date: Feb 12, 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-0217-2025 ↗

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