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# FDA Update on Ranitidine Contaminant Testing
- URL: https://www.fdaweb.com/fda-update-on-ranitidine-contaminant-testing/
- Published: 2019-10-02T12:00:00.000Z
- Updated: 2026-09-15T01:53:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145146

FDA says it is continuing to test ranitidine products ([see earlier story](https://www.fdaweb.com/carcinogen-ndma-now-spreads-to-heartburn-drugs/)) from multiple manufacturers and is assessing the potential impact on patients who have been taking the product that has been found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA). In addition, the agency has asked ranitidine manufacturers to conduct their own laboratory testing to assess NDMA levels and to send samples of ranitidine products to FDA to be tested by its scientists. To date, the agency says its early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables.

An updated [FDA notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=260582&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=8ddd09a9f14141dc8c75df0d43fe324b&elqaid=9722&elqat=1&ref=fdaweb.com) says that a testing method used by a third-party laboratory uses higher temperatures than recommended. “The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure,” it says. FDA earlier published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities, but that method is not suitable for testing ranitidine because heating the sample generates NDMA, it adds.

FDA recommends using an [LC-HRMS](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20provides%20update%20on%20testing%20of%20ranitidine%20for%20NDMA%20impurities&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=9911&elqTrackId=21B149846764BA8288BA349592376372&elq=8ddd09a9f14141dc8c75df0d43fe324b&elqaid=9722&elqat=1) 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,” it says.