Approximately 1,211,626 bottles of various blood pressure medications, including Valsartan and Amlodipine/Valsartan combinations, have been recalled because they contain trace amounts of N-nitrosodiethylamine (NDEA). This impurity was found in the active pharmaceutical ingredient (API) used to manufacture these drugs in India. The recall affects several strengths and bottle sizes of Mylan Pharmaceuticals products distributed across the United States and Puerto Rico.
NDEA is a substance that occurs naturally in certain foods and drinking water, but it is classified as a probable human carcinogen. While trace amounts were found, long-term exposure to this impurity above acceptable levels may increase the risk of cancer.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
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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