FDA Drug · D-0217-2025

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.

Class II · Terminated

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

Affected lots / codes — check yours against thisLot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.

Recalling firm: RemedyRepack Inc., Indiana, PA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 247 blister packs
Distribution: FL
Recall initiated: January 24, 2025
Classified: February 3, 2025
Terminated: July 17, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0217-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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