Pharmacy Services Alerts
Some Ranitidine (Zantac) Products May Contain a Probable Carcinogen
Nov 13, 2019 8:20 AM
Some ranitidine products, including brand-name Zantac, may contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is an environmental contaminant found in various foods and water. Concentrations of NDMA in ranitidine products barely exceeded amounts found in common foods in preliminary tests conducted by FDA. FDA is evaluating whether these low concentrations pose a risk to patients. FDA is working with international regulatory agencies and manufacturers to identify the source of NDMA contamination, and will provide updated information when available.
Ranitidine is a histamine-2 antagonist available in both prescription and over-the-counter forms. It decreases stomach acid production, and prevents and treats heartburn and gastrointestinal ulcers. Patients do not need to stop taking ranitidine at this time. Patients taking prescription ranitidine should discuss other treatment options with their health care provider before stopping therapy. Patients taking over-the-counter ranitidine can consider using a different medication approved for the same condition.
Patients and health care providers can report any adverse reaction related to ranitidine therapy to FDA’s MedWatch Program in 1 of 2 ways.
- Submit a report online at www.fda.gov/medwatch/report.htm
- Complete a paper form and fax to 1-800-FDA-0178
Additional information is available at the following links:
- MedWatch Alert:
- Press Announcement:
- Ongoing list of press alerts for NDMA in ranitidine products:
- NDMA in ranitidine FAQ:
- Manufacturer Recalls
- American Health Packaging – repackaged Lannett 15 mg/mL oral solution (11/8/19)
- Amneal – specific lots of tablets and syrup (11/12/19)
- Apotex – all formats and pack sizes (9/25/19)
- Aurobindo – 38 lots of tablets, capsules, and syrup (11/06/19)
- Dr. Reddy’s – all unexpired tablet and capsule presentations (10/23/19)
- Lannett – all unexpired lots of ranitidine 15 mg/mL oral solution (also called ranitidine syrup) (10/25/19)
- Novidium Pharma – all tablet strengths and pack sizes (10/25/19)
- Perrigo – all formats and pack sizes (10/23/19)
- Sandoz – all unexpired capsule presentations (9/23/19)
- Sanofi – all over-the-counter presentations (10/23/19)