Amneal Pharmaceuticals has voluntarily recalled several strengths and sizes of Ranitidine Tablets (150 mg and 300 mg) and Ranitidine Syrup Oral Solution (15 mg/mL) because testing discovered an impurity called N-nitrosodimethylamine (NDMA) in the active ingredient. Ranitidine is a common medication used to treat stomach ulcers and heartburn. The recall includes various bottle sizes ranging from 30-count to 1000-count bottles sold nationwide between 2019 and 2021. Consumers should contact their doctor or pharmacist immediately to discuss alternative treatments, as this medication may contain a substance classified as a probable human carcinogen.
The recalled products contain N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. While NDMA is a known environmental contaminant found in water and foods, its presence in medication at levels higher than acceptable limits poses an increased risk of cancer over long-term exposure.
Refund and guidance for alternative medication.
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.