Glenmark Pharmaceuticals recalled 17,496 bottles of Carvedilol Tablets on August 6, 2025. Tests revealed N-Nitroso Carvedilol Impurity-1 levels exceeded FDA limits. Consumers should stop using the medication immediately.
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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The recall affects Carvedilol Tablets, USP, 12.5 mg, packaged in cartons of 500 tablets. The affected lot numbers are 17241257, 17241258, and 17241279, with an expiration date of June 2026. The product was distributed nationwide in the USA.
The recall stems from CGMP deviations that resulted in N-Nitroso Carvedilol Impurity-1 levels above the FDA-recommended limit of no more than 4.0 ppm. This impurity is a potential health risk.
There have been no reported injuries or deaths associated with this recall. The impurity issue is classified as a significant concern due to the potential health effects of long-term exposure.
Stop using the recalled Carvedilol Tablets immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for further guidance and potential alternatives.
For more information, consumers can visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0587-2025 or call Glenmark Pharmaceuticals Inc.
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