FDA announces voluntary recall of certain ranitidine products for impurities

Ranitidine is an over-the-counter (OTC) and prescription medication, also known as the brand name Zantac®.  This medication works to lower the amount of acid the stomach makes by blocking H2 (histamine-2).  People buy this product OTC to prevent and treat heartburn caused by stomach acid or sour stomach, and a doctor may prescribe this medication for preventing ulcers in the stomach or intestines and/or for gastroesophageal reflux disease (GERD).

In September 2019, the Food and Drug Administration (FDA) released a statement to inform the public that some ranitidine products were found to have low amounts of an impurity called N-nitrosodimethylamine (NMDA).

NMDA comes from the environment and is often found contaminating water, meats, dairy, and vegetables. Based on laboratory tests, this substance also is known to be a “probable carcinogen”, or a substance that could cause cancer.

Ranitidine Recall

Following the FDA’s announcement, some drug companies that make OTC ranitidine tablets (75mg and 150mg), and one drug maker of prescription ranitidine capsules, have volunteered to recall their products as a precaution.

OTC products labeled by Walgreens, Walmart, Rite Aid, and Apotex Corp, as well as prescription ranitidine capsules (150mg and 300mg) from Sandoz Inc. have been recalled by the companies.  The FDA is working to find out if there is any risk to using the contaminated medication and where the impurity came from.  It is important to know that not all ranitidine products in the U.S. are being recalled, and the FDA recommends people can keep taking ranitidine medications that have not been recalled.

What you should know:

• OTC ranitidine labeled by Walgreens, Walmart, Rite Aid, and Apotex Corp. have been recalled by the drug makers as a precaution.
• Prescription ranitidine capsules made by Sandoz Inc. have been recalled by the company as a precaution.
• If the ranitidine medication you take is one of the brands listed above as recalled and matches one of the product numbers found on the FDA report pages below (Resources 3 and 4), you should stop taking it and contact the respective company with any questions.
• If you take OTC ranitidine (without being told by your doctor), you might consider switching to another OTC medication that also treats your condition. The most similar OTC medications to ranitidine are famotidine (Pepcid®) and cimetidine (Tagamet®). Be sure to ask your pharmacist or doctor if it is safe to take any new medications with your other medications or conditions.
• If you are prescribed ranitidine by your doctor and wish to stop, talk to your doctor about other options.
• If you experience any side effects or reactions to ranitidine, you should report it to the FDA’s MedWatch program, which tracks any issues with medications after they are on the market and helps us understand how big of a problem there may be. To report, follow one of the steps below:
  • Complete and submit a report online at fda.gov/medwatch/report.htm
  • Download form (https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda), or call 1- 800-332-1088 to request a reporting form, then complete and submit it to the address on the form or by fax at 1-800-FDA-0178

Resources:

• Original FDA report: https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
• Updates: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
• Sandoz FDA alert: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
• Apotex, Walgreens, Walmart, & Rite Aid FDA alert: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and