More Ranitidine (Zantac) Recalls Issued Over Possible Carcinogen NDMA

On Nov. 4, I blogged about the Food & Drug Administration’s (FDA’s) public statement announcing the detection of N-nitrosodimethylamine (NDMA) in preliminary tests of the heartburn medication ranitidine, which is most often sold under the brand name Zantac. NDMA is a chemical agent categorized as a probable human carcinogen, which means it likely causes cancer.

The statement came after the Connecticut-based online pharmacy Valisure sent a warning letter to the FDA alerting it of extremely high levels of NDMA being detected in multiple ranitidine medications that were tested. Valisure detected up to 3,00,000 nanograms (ng) of NDMA in some ranitidine medications, which is over 30,000 times the recommended daily intake limit of 96 ng set by the FDA.

At the time of my first blog post on this topic, several drug makers had already issued voluntary recalls of various ranitidine medications:

• Apotex Corp. – Ranitidine 75 and 150 mg tablets (all pack sizes)
• Reddy’s Laboratories – Ranitidine over-the-counter medications (expiration dates from September 2019 to June 2021)
• Lannett Company, Inc. – Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
• Novitium – Ranitidine Hydro-chloride prescription capsules (30, 60, 100 and 500-count)
• Perrigo Co. – Ranitidine over-the-counter medications (all pack sizes)
• Sandoz Inc. – Ranitidine 150 mg capsules (30, 60 and 500-count)
• Sanofi – Zantac 150®, Zantac 150® Cool Mint and Zantac 75® over-the-counter medications

Since then, a number of additional ranitidine medications were recalled over the same NDMA cancer concerns:

• Aurobindo & DG Health – Ranitidine
• AHP – Ranitidine Liquid Unit Dose Cups
• Amneal – Ranitidine Tablets, 150 and 300 mg tablets, Ranitidine Syrup, 15 mg/mL

The FDA is investigating ranitidine, which is prescribed in the U.S. more than 15 million times per year, to uncover what’s behind the NDMA contamination. Additionally, researchers at the Memorial Sloan Kettering Cancer Center are working to determine whether ranitidine users are at a heightened risk for developing cancer.

If you or a loved one developed cancer after taking ranitidine (Zantac), please give the dangerous drug and device attorneys at Childers, Schlueter, & Smith a call at 800-641-0098 or fill out our online contact form. All initial inquiries are free of charge and without obligation.