FDA Recall D-0587-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 281 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05

Lot / code: Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026

Quantity: 17, 496 bottles

Reason for recall

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 record

Recall number: D-0587-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA
Recall initiated: 2025-08-06
Classified by FDA Center: 2025-08-14
FDA published: 2025-08-20
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): CARVEDILOL
Generic name(s): CARVEDILOL
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-162, 68462-163, 68462-164, 68462-165
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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