FDA Updates on NDMA in Zantac

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

Perrigo Company 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 is voluntarily recalling all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine.

Lannett 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.

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The full information regarding all ranitidine recalls can be found on the FDA website.

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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