Global Heartburn Medicine Recall Hits CNY

Versions of Zantac and other forms of ranitidine found to have small amounts of a cancer-causing substance and is being pulled off store shelves worldwide.

The FDA has learned that some ranitidine medicines, products commonly known as Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Canadian drugmaker Apotex Inc. has recalled its 75 mg and 150 mg over-the-counter ranitidine tablets made for Walgreens, Walmart and Rite-Aid. CVS is also pulling the product off store shelves.

[9/26/19] The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg) ... These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid ingestion and sour stomach, may consider using other OTC products approved for their condition.

What patients should know

• Not all ranitidine medicines marketed in the U.S. are being recalled.
• FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
• Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.