FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Update: The U.S. Food and Drug Administration is alerting health care professionals and patients to three voluntary recalls of ranitidine.

  • Perrigo Company plc is voluntarily recalling over-the-counter (OTC) ranitidine tablets (all pack sizes) due to the potential of N-Nitrosodimethylamine (NDMA) in the medicine.
  • Novitium Pharma LLC is voluntarily recalling all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine.
  • Lannett Company, Inc. is voluntarily recalling all unexpired lots of prescription ranitidine syrup (ranitidine oral solution, USP, 15mg/mL) due to the presence of NDMA found in the drug.

Refer to the FDA’s recalls webpage for up-to-date information about recalls of ranitidine.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s testing of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these medicines.

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