FDA Discovers NDMA in Ranitidine Syrup During Zantac Investigation

The Zantac recall continues to expand as health investigators test more batches of the popular heartburn drug for carcinogens. On October 25, the FDA just announced the discovery of NDMA in not just ranitidine tablets, but in syrups as well.

Last week, pharmaceutical manufacturer Lannett Company recalled all lots of their generic ranitidine syrup after discovering high levels of NDMA, a known human carcinogen. According to their safety announcement, the levels of NDMA found in Lannett's ranitidine syrups exceeded FDA safety standards.

Over the last few weeks, pharmaceutical companies and retailers across the world have issued constant streams of Zantac recalls for both over-the-counter and generic versions of the drug. On September 13, the FDA first announced their discovery of NDMA contamination in both Zantac and ranitidine, the generic version of Zantac. So far, Zantac recalls have been issued in Canada and France, with ranitidine recalls pending or under way in Australia, Germany, and the US among other countries.

N-Nitrosodimethylamine (NDMA) is a chemical the FDA classifies as a “probable human carcinogen, a substance that can cause cancer,” and has been the source of several recalls over the last couple years. Now, individuals across the world are raising cancer concerns over contaminated Zantac medications.

Lannett Company was first alerted by FDA of the presence of NDMA in generic ranitidine September 17, 2019 and immediately started testing their own ranitidine syrups. Their results discovered levels of NDMA that were higher than the FDA’s permissible daily limit of the carcinogen. This seems to be the first recall of ranitidine not in tablet form.

Lannett’s ranitidine recall affects all lots of their ranitidine syrup within the expiration date of Ranitidine Syrup (Ranitidine Oral Solution, USP) 15mg/mL. These batches are packaged in 16 fluid ounce bottles (1 pint) with an NDC code of 54838-550-80.

Zantac Cancer Scare

With the discovery of NDMA in Zantac, thousands of individuals in the US may be at risk of developing cancer from contaminated medication. Growing numbers of Zantac lawsuits are being filed by individuals claiming their bladder, stomach, small intestine, and other cancers were caused by NDMA in their ranitidine medications.