Carvedilol 25 mg Tablet recalled over manufacturing violations

Recall date

January 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ…

Recall number

D-0217-2025

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

FL

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.