FDA Update for Ranitidine (Zantac) Recall

Posted: Oct 01, 2019

While online recently, I came across a news article about a worldwide recall for a popular medicine. 

Popularly known as the brand name Zantac, ranitidine is a medication I frequently recommend for patients.  It is an inexpensive medicine that is well-tolerated and works wonders for those who are suffering from the effects of acid reflex and other similar conditions.

It was alarming to see that such a wonderful medication was being criticized, and I immediately began to investigate for myself.

The U.S. Food & Drug Administration (FDA) website is an excellent and reliable source of information, and I was reassured by their concise explanation of the issue at hand.

As of today,  there is not a mandatory recall for any of the batches of ranitidine in the United States.

In certain batches of ranitidine from a particular manufacturer, the FDA found trace amounts of a chemical known as N-nitrosodimethylamine (NDMA).  This chemical is known to cause cancer with extended exposure. The batches of ranitidine with this chemical were sold at Wal-Mart, Walgreens, and Rite-Aid stores.

I will repeat: only microscopic amounts of this chemical were found in specific batches of ranitidine in the U.S. earlier this year, and ranitidine currently sold in those stores are contaminant-free.

There is no cause for panic or immediate discontinuation of your ranitidine without consulting your healthcare provider.

The FDA has recommended a voluntary recall of the medication, meaning you should keep taking the medication as prescribed by your medical provider, even if you purchased it from any of the retailers listed above.

If you purchased ranitidine from any retailer other than those listed above: Good news, you’re in the clear! The FDA has not found any contaminant in ranitidine from those suppliers.

You should consult your healthcare provider about alternatives that will be best for you before discontinuing any medication.

We at Button Family Practice are happy to speak with you more about this recall and may be able to suggest an alternative medication based on your individual circumstances.

Jeremy Johnson, PA-C
Button Family Practice, PC

References:

Center for Drug Evaluation and Research. NDMA in Zantac (ranitidine). https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. Published September 26, 2019. (Accessed October 1, 2019.)

Ranitidine: drug information. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com (Accessed on October 01, 2019.)