FDA alerts patients and health care professionals to voluntary recalls of ranitidine manufactured by Amneal and American Health Packaging (manufactured by Lannett Company).

FDA alerts patients and health care professionals to voluntary recalls of ranitidine manufactured by Amneal and American Health Packaging (manufactured by Lannett Company).

FDA is alerting patients and health care professionals to two voluntary recalls of ranitidine.

• Amneal voluntarily recalled prescription ranitidine hydrochloride tablets (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Amneal Pharmaceuticals LLC. These medications contain unacceptable levels of N-nitrosodimethylamine (NDMA).
• American Health Packaging also voluntarily recalled eight lots of ranitidine syrup (150 mg/10 mL) liquid unit dose cups, manufactured by Lannett Company.

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.

Consumers taking over-the-counter (OTC) ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.

For more information, please visit: NDMA in Zantac (ranitidine).