Zantac® (ranitidine) recalls continue amidst investigation of possible contamination

What you need to know about the Zantac and generic ranitidine recalls

Updated: January 9, 2020

• There have been low levels of a probable human carcinogen detected in some ranitidine products
• This impurity is known as an environmental contaminant and also found in water and certain foods
• No reports of adverse events related to its presence in these products have been reported
• FDA will continue to investigate and test ranitidine products from multiple manufacturers
• There may be more ranitidine products recalled in the coming months
• Zantac (ranitidine) is available OTC and by prescription in several strengths and formulations
• Some pharmacy chains - CVS, Walgreens, Walmart, Rite-Aid - have pulled ranitidine products from their shelves
• Consumers should talk to their healthcare professionals to determine if they should continue taking their medication, transition to another ranitidine product or different medication in the same class (e.g., famotidine, nizatidine), also available over-the-counter and by prescription
• The first recall was announced on ​September 23, 2019

As of the date of publication, the following companies have recalled Zantac and ranitidine products. For more specific manufacturer information, click on their name below:

• American Health Packaging
• Amneal Pharmaceuticals LLC
• Apotex Corp.
• Appco Pharma LLC (ANI Pharmaceuticals)
• Aurobindo Pharma USA
• Denton Pharma, Inc. (Northwind Pharmaceuticals)
• Dr. Reddy’s Laboratories Ltd.
• Glenmark​
• Golden State Medical Supply
• Lannett Company, Inc
• Novitium Pharma
• Novartis (Sandoz)
• Perrigo
• Precision Dose Inc.
• Sanofi

Please visit our Clinical Connection page periodically for updates and alerts related to any future recalls.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration. Company Announcement. Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product. September 23, 2019. Available at: ttps://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated.
2. U.S. Food and Drug Administration. FDA News Release. FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity. September 24, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity.
3. U.S. Food and Drug Administration. Company Announcement. Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) Impurity in the product. September 25, 2019. Available at: 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
4. Sanofi Press Releases. Sanofi to conduct precautionary voluntary recall of Zantac OTC in U.S. and Canada. October 18, 2019. Available at: http://www.news.sanofi.us/2019-10-18-Sanofi-to-conduct-precautionary-voluntary-recall-of-Zantac-OTC-in-U-S-and-Canada
5. U.S. Food and Drug Administration. Company Announcement. Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market. October 23, 2019. Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market.
6. U.S. Food and Drug Administration.  Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product. Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n?
7. U.S. Food and Drug Administration.  Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg
8. U.S. LANNETT ISSUES VOLUNTARY NATIONWIDE RECALL OF RANITIDINE SYRUP Available at: https://www.lannett.com/product-alerts/lannett-issues-voluntary-nationwide-recall-of-ranitidine-syrup/