Ranitidine OTC and prescription recall (including brand name Zantac)
This drug has been recalled.
On April 1, 2020, The U.S. Food and Drug Administration (FDA) issued a withdrawal of all prescription and over-the-counter (OTC) ranitidine (brand name Zantac) drugs. The recall is because the (FDA) announced the request to withdraw all prescription and OTC ranitidine drugs from the market immediately due to the presence of N-Nitrosodimethylamine (NDMA). NDMA is classified as a substance that could cause cancer. Ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
What should you do now?
Patients taking prescription or OTC ranitidine should speak with their health care provider about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.
- Mix the medicine with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush tablets or capsules.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in the trash at home.
- Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.
Please reach out to your patient(s) to discuss alternative treatments, if needed.