Glenmark Pharmaceuticals recalled 14,976 bottles of Carvedilol Tablets on August 6, 2025. The recall follows findings of N-Nitroso Carvedilol Impurity-1 above FDA limits. Consumers should stop using the product immediately and contact their healthcare provider.
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
The recall involves Carvedilol Tablets, USP, 25 mg, packaged in 500 tablets per carton. The affected lot numbers are 17241213, 17241215, and 17241224, with an expiration date of June 2026.
The recall stems from CGMP deviations, specifically elevated levels of N-Nitroso Carvedilol Impurity-1 (NNCI) exceeding the FDA-recommended limit of 4.0 ppm. This impurity poses potential health risks.
No injuries or incidents have been reported related to this recall. The hazard level is classified as high due to the potential risks associated with the impurity.
Consumers and healthcare providers should stop using Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc., USA, or your healthcare provider for further guidance.
For more information, consumers can visit the FDA's recall page or contact Glenmark Pharmaceuticals Inc. at their USA office.
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