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Safety notice: Withdrawal of all ranitidine products

Provider news | Monday, July 6, 2020

On April 1, 2020, the U.S. Food and Drug Administration (FDA) asked manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine (Zantac) products from the market due to potential contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Low levels of NDMA are commonly found in certain foods and water and are not expected to increase the risk of cancer in humans. However, NDMA levels found in some ranitidine products may increase over time and when stored at higher than room temperature, which may lead to unacceptable levels of exposure.

Health professionals should advise patients about other treatment options before stopping ranitidine. There are other drugs approved for the same or similar indications as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA present in famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole.

You may view the SCFHP Medi-Cal Formulary or the SCFHP Cal MediConnect List of Covered Drugs (Formulary) for covered alternatives.

Side note: In light of the current COVID-19 pandemic, instead of taking unused medicines to a drug take-back location, the FDA recommends that patients and consumers follow the specific disposal instructions in the medication guide or drug package insert, or follow the FDA’s recommended steps for proper disposal.

Read more about the withdrawal of ranitidine products on the FDA and the DHCS websites.

Read more news in the July issue of Provider e-News