Update [1/8/2020] The U.S. Food and Drug Administration is alerting health care professionals and consumers to Mylan’s voluntary recall of prescription nizatidine capsules. The medicines may contain unacceptable levels of the nitrosamine, N-nitrosodimethylamine (NDMA). Nizatidine is a commonly prescribed antacid.

NDMA is a known environmental contaminant found in water and certain foods. Genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.

In September 2019, FDA announced it had become aware of laboratory testing that found low levels of NDMA in the heartburn medicine, ranitidine, which is chemically similar to nizatidine. FDA has been testing samples of both ranitidine and nizatidine.  The agency has also asked manufacturers of the drugs to conduct their own laboratory testing to assess levels of NDMA in their products and to send samples to FDA to be tested by our scientists. FDA will recommend recalls to manufacturers of ranitidine and nizatidine with NDMA levels above the acceptable daily intake limit (96 nanograms per day).

There are multiple drugs that are approved for the same or similar uses as ranitidine and nizatidine. Patients taking prescription ranitidine or nizatidine who wish to stop use should talk to their health care professional about other treatment options. If you are taking one of the recalled medicines, you should follow the recall instructions provided by the company. This information is on the FDA’s website.

FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since 2018. FDA has recommended numerous recalls of ARBs as it discovered unacceptable levels of nitrosamines.

FDA is committed to helping assure the medicines Americans take are safe and effective. When we identify lapses in the quality of drugs that pose potential risks for patients, FDA makes every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible.

FDA will continue to investigate and work to make certain these types of impurities do not exceed acceptable limits, so that patients can continue taking their medicines without concern. The agency will provide timely updates throughout the investigation.

FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program: