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# Apotex Recalls Some OTC Ranitidine Tablets
- URL: https://www.fdaweb.com/apotex-recalls-some-otc-ranitidine-tablets/
- Published: 2019-09-26T12:00:00.000Z
- Updated: 2026-09-15T01:52:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145104

FDA says Apotex is recalling over-the-counter ranitidine tablets (75 mg and 150 mg), a generic form of Novartis’ Zantac labeled by Walgreens, Walmart, and Rite-Aid. An agency [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine?ref=fdaweb.com) says the recalled tablets may contain low levels of a nitrosamine impurity, N-nitrosodiemthylamine (NDMA), which is classified as a probable human carcinogen.

“The recall follows a recent FDA [statement](https://www.fdaweb.com/carcinogen-ndma-now-spreads-to-heartburn-drugs/) about NDMA impurities detected in ranitidine medicines,” the statement says. “The agency also recently alerted patients and healthcare professionals of Sandoz’ voluntary [recall](https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity?utm%5Fcampaign=FDA%20alerts%20health%20care%20professionals%20and%20patients%20to%20voluntary%20recall%20of%20ranitidine%20medicines&utm%5Fmedium=email&utm%5Fsource=Eloqua) of prescription ranitidine HCl capsules due to an NDMA impurity on 9/23.”

The notice says that not all ranitidine medicines marketed in the U.S. are being recalled and the agency is not recommending that individuals stop taking ranitidine medicines at this time.

FDA says it is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking the drug. And it has asked manufacturers to conduct laboratory testing to examine NDMA levels in ranitidine and to send drug samples to FDA for testing by its staff.