Public Affairs
Regional Health Command-Europe
SEMBACH KASERNE, Germany – The U.S. Food and Drug Administration recently recommended a nationwide voluntary recall of Ranitidine (also known by its brand name, Zantac) for several prescription-strength and over-the-counter ranitidine products.
Prescription strength ranitidine in 150 mg and 300 mg tablets, and 15 mg/mL Ranitidine Syrup (Ranitidine Oral Solution, USP) are involved in the recommended recall. These specific products can only be obtained by prescription. Several manufacturers have also voluntarily recalled their over-the-counter ranitidine products.
Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
According to an FDA news release, the recall recommendation was made because of potential N-Nitrosodimethylamine (NDMA) amounts that exceed levels established by the FDA.
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
Patients who wish to stop taking prescription ranitidine should talk to their health care professional about other treatment options. There are multiple drugs approved for the same or similar uses as ranitidine.
Anyone who has purchased over-the-counter ranitidine should contact the retail store where it was purchased to find out if that particular product has been recalled, or visit the FDA website for more information: https://go.usa.gov/xpRVS
As with all medications, excess ranitidine should be disposed of in accordance with local waste management regulations.