FDA Alerts Health Care Professionals and Patients to Mylan’s Voluntary Recall of Nizatidine

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.