Glenmark Pharmaceuticals recalled 44,328 bottles of Carvedilol Tablets, USP, 3.125 mg on August 7, 2025. The recall follows the discovery of N-Nitroso Carvedilol I impurity above acceptable levels. Consumers should stop using this medication immediately and consult their healthcare providers.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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 includes Carvedilol Tablets in 500-count bottles (NDC 68462-162-05) and 100-count bottles (NDC 68462-162-01). These products were distributed nationwide in the USA and manufactured by Glenmark Pharmaceuticals Ltd in Goa, India.
The recall was issued due to CGMP deviations resulting in the presence of N-Nitroso Carvedilol I, a nitrosamine impurity. This impurity is above the current acceptable intake level, which poses potential health risks to consumers.
No specific injuries or incidents have been reported related to this recall. The FDA classified this recall as Class II, indicating a potential health hazard.
Consumers and healthcare providers should stop using the affected Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc. or your healthcare provider for further guidance and to discuss possible alternatives.
For more information, consumers can call Glenmark Pharmaceuticals Inc. or visit their official website. The recall notification has also been sent via letter.
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