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

QA on NDMA in ranitidine

Nitrosamine Impurities in Medications


Update [1/8/2020] FDA is alerting patients and health care professionals to two voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

  • Appco Pharma LLC is voluntarily recalling prescription ranitidine hydrochloride capsules.
  • Northwind Pharmaceuticals is voluntarily recalling prescription ranitidine tablets (150 mg and 300 mg), manufactured by Glenmark Pharmaceutical Inc.

FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

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
  • LC-MS/MS method: An alternative method for the detection of NDMA in ranitidine drug substance and drug products. This method is based on a triple-quadrupole MS platform.