Lupin Pharmaceuticals Inc. has voluntarily recalled 492,858 bottles of Metformin Hydrochloride Extended-Release Tablets (500 mg and 1000 mg), a medication used to control blood sugar in adults with type 2 diabetes. The recall was initiated because FDA laboratory testing found levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. These prescription medications were distributed nationwide in bottles of 60, 90, or 100 tablets. Consumers should contact their healthcare provider or pharmacist for guidance on continuing their treatment or obtaining a replacement.
NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above the acceptable limit may increase the risk of cancer. While no immediate injuries or adverse events have been reported, the levels detected in these specific batches failed to meet safety standards for pharmaceutical purity.
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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