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

QA on NDMA in ranitidine

Update [10/2/19] FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. In addition, the agency has asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA in their ranitidine products and to send samples of ranitidine products to FDA to be tested by our scientists.

FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.

FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA’s LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.

FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation. To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.

[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), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. 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.

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.

This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of prescription ranitidine hydrochloride capsules due to an NDMA impurity on Sept. 23.

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.

What health care professionals should know

  • Multiple drugs are approved for the same or similar uses as ranitidine. Health care professionals should discuss other treatment options with patients who are concerned about ranitidine.
  • If you have samples of recalled ranitidine, do not provide them to patients.

FDA’s actions

FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine. Additionally, FDA recently posted a testing method, which can be used by regulators and industry to detect nitrosamine impurities in ranitidine. FDA has asked ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in ranitidine and to send samples of ranitidine to the agency to be tested by our scientists.

FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity.

FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available.

Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA's MedWatch program to help the agency better understand the scope of the problem:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities
The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in ranitidine drug substances and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
  • LC-HRMS method: an LC-MS method for the detection of NDMA in ranitidine drug substance and drug products