AVKARE Inc. has recalled approximately 735,935 bottles of Ranitidine Tablets (both 150 mg and 300 mg strengths), a medication used to treat stomach acid conditions. The recall was initiated because the tablets may contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. These prescription-only medications were distributed nationwide in various bottle sizes ranging from 30 to 1000 tablets. Consumers should check their prescription bottles against the specific lot numbers and expiration dates to determine if their medication is affected.
The medication contains NDMA, an environmental contaminant found in water and foods. While it may be present in low levels, the levels found in these specific lots of Ranitidine exceed acceptable safety limits, and long-term exposure to high levels of NDMA is linked to an increased risk of cancer.
Drug recall refund/return
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 ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.