Glenmark Pharmaceuticals recalled 6,432 bottles of Carvedilol Tablets on August 7, 2025. The recall stems from CGMP deviations due to the presence of a nitrosamine impurity above acceptable levels. Consumers should stop using the product immediately and contact healthcare providers for guidance.
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 involves Carvedilol Tablets, USP, 12.5 mg, sold in 500-count bottles. The product was manufactured by Glenmark Pharmaceuticals Ltd and distributed nationwide in the USA.
The recall is due to deviations from Current Good Manufacturing Practices (CGMP). The tablets contain N-Nitroso Carvedilol I, a nitrosamine impurity, exceeding the current acceptable intake level.
No specific incidents or injuries have been reported at this time. The risk level is classified as high due to the potential health implications associated with nitrosamine exposure.
Consumers should stop using Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc. or a healthcare provider for further assistance.
For more information, visit Glenmark Pharmaceuticals at their official website or contact them directly.
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