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Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)

Answers to questions about NDMA impurities found in ranitidine and FDA’s actions to address the issue

Updates on NDMA in ranitidine

Important information about NDMA impurities in ranitidine products

  • The U.S. Food and Drug Administration has requested a manufacturer’s market withdrawal of ranitidine, known commonly by the brand name Zantac. This means ranitidine products will not be available for new or existing prescriptions or over-the-counter (OTC) use in the U.S.
  • FDA has found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumers, and therefore the agency has requested the withdrawal of all ranitidine products from the U.S. market.
  • Consumers should stop taking any OTC ranitidine they may currently have. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine. Multiple drugs are approved for the same or similar uses as ranitidine.
  • Consumers should dispose of any ranitidine products properly, and not buy more of it including compounded ranitidine.
  • To date, FDA’s testing has not found NDMA in products used for similar treatment like famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
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