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FDA Wants All Zantac (Ranitidine) Products Taken off the U.S. Market

Update [April 1st, 2020]

For Immediate Release:

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

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


Update [10/28/19] The U.S. Food and Drug Administration is alerting health care professionals and patients to more voluntary recalls of ranitidine, a common medication found in a wide variety of heartburn medications – prescribed and over-the-counter.  See the list below of all voluntary recalls to date:

  • 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.
  • Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
  • Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.
  • Rantidine distributed to Walgreen, Walmart, CVS, and Rite Aid have also been voluntary removed from store shelves. Check the list on the FDA webpage that includes lot numbers.

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.

Risk Statement: NDMA is classified as a probable human carcinogen, based on a fact sheet by the EPA, and is a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables.








By |2020-04-02T08:26:44+00:00April 1st, 2019|Local News, Recalls|0 Comments