Glenmark Pharmaceuticals Inc., USA is voluntarily recalling several lots of Glenmark Carvedilol (carvedilol) Tablets in 12.5 mg and 25 mg strengths. The recall was issued because tests revealed levels of an impurity called N-Nitroso Carvedilol I (NNCI-I) that exceed the current FDA recommended safety limits. Consumers currently taking this prescription medication for high blood pressure or heart failure should not stop treatment without first consulting their healthcare provider or pharmacist to discuss alternatives.
The impurity NNCI-I is a nitrosamine, which is classified as a probable human carcinogen. While there is no immediate health risk, long-term exposure to this impurity above recommended limits may increase the risk of cancer.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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