Glenmark Pharmaceuticals Inc., USA is recalling 55,560 bottles of Carvedilol Tablets, USP, used to treat high blood pressure and heart failure. The recall affects 3.125 mg, 12.5 mg, and 25 mg strengths distributed nationwide. Laboratory testing detected a nitrosamine impurity, N-Nitroso Carvedilol I, at levels exceeding the acceptable daily intake limit set by the FDA. If you are taking this medication, do not stop taking it without first consulting your healthcare provider or pharmacist, as the risk to your health may be greater if the condition is left untreated.
Long-term exposure to nitrosamine impurities above acceptable intake levels may increase the risk of cancer. No immediate health risks have been reported, but the impurity exceeds safety thresholds established for chronic use.
You have 2 options:
Packaged in 500-count or 100-count bottles.
Packaged in 500-count bottles.
Packaged in 500-count bottles.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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