Glenmark Pharmaceuticals recalled 4,800 bottles of Carvedilol Tablets on August 7, 2025. The recall stems from CGMP deviations leading to high levels of nitrosamine impurities. Consumers should stop using the product immediately and consult 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 recalled product is Carvedilol Tablets, USP, 25 mg, in 500-count bottles. The National Drug Code (NDC) is 68462-165-05. These tablets were distributed nationwide in the USA.
The recall involves the presence of N-Nitroso Carvedilol I impurity above acceptable intake levels. This contamination poses a significant health risk to consumers.
No specific incidents or injuries have been reported in connection with this recall. The risk level is classified as high due to the potential health implications.
Consumers should stop using Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc., USA, or consult your healthcare provider for further guidance.
For more information, call Glenmark Pharmaceuticals Inc. at 1-800-XXX-XXXX or visit their website. Additional details are available at the FDA's recall page.
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