Glenmark Pharmaceuticals Inc., USA recalls 17,496 bottles of Carvedilol tablets sold nationwide after NNCI impurity exceeded FDA limits. The recall covers lot numbers 17241257, 17241258, and 17241279 with Exp. Date 06/2026. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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Carvedilol is a beta-blocker used to treat high blood pressure and heart failure. This recall concerns impurities in the product rather than a device malfunction.
NNCI impurity above FDA limits may pose health risks. The exact health effects are not specified in the notice.
This recall is not described as part of a broader industry pattern.
Immediate halting of use is advised. Affects patients currently prescribed carvedilol with these lots.
FDA enforcement page for D-0587-2025 and Glenmark recall notices.
Refunds/replacements follow manufacturer processes, typically weeks to a few months.
Keep recall letter, prescription records, bottle labels, and correspondence with manufacturer.
Product: Carvedilol Tablets, USP 12.5 mg. Quantity: 17,496 bottles. Manufacturer: Glenmark Pharmaceuticals Ltd., India. Distributed by Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430. NDC 68462-164-05. Lot numbers: 17241257, 17241258, 17241279. Expiration: 06/2026. Distribution: Nationwide in the USA. Status: Active recall as of 2025-08-06.
No specific consumer injuries or adverse event reports are mentioned in the recall notice.
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