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Zantac® Recalls Due to NDMA Contamination

In early September 2019, the news broke that tests had found “extremely high levels” of the cancer-causing chemical NDMA1 in Zantac and other ranitidine2 products. A few days later, the Food and Drug Administration (FDA) announced that its own “preliminary” tests had also found unsafe (though lower) levels of NDMA in some batches of Zantac and other ranitidine medicines. A series of voluntary recalls began soon thereafter.

Health Canada also began assessing the NDMA levels in ranitidine products. It asked manufacturers to stop distributing Zantac and other ranitidine products in Canada until their NDMA levels were known to be safe, and it announced recalls for many Canadian ranitidine products.

In late September 2019, the makers of Zantac and generic ranitidine products began recalling many batches of their products due to potential NDMA contamination, and many stores pulled unrecalled products from their shelves.

  • On September 23, 2019, Sandoz recalled all 14 unexpired lots of the generic Ranitidine Hydrochloride Capsules it sells in the United States due to unsafe levels of NDMA.
  • On September 25, 2019, Apotex Corporation recalled the 75 mg and 150 mg generic Ranitidine Tablets it supplied to Walmart, Rite Aid, and Walgreens in the United States due to possible NDMA contamination.
  • On September 30, 2019, CVS and Walgreens announced they were suspending sales of Zantac and all generic ranitidine products due to possible NDMA contamination.
  • On October 2, 2019, Walmart and Kroger announced they were suspending sales of Zantac and all generic ranitidine products due to possible NDMA contamination.
  • On October 22, 2019, Sanofi announced a voluntary recall of all Zantac brand products sold over the counter in the United States due to potential NDMA contamination.
  • On October 23, 2019, Perrigo Company plc announced a worldwide recall of its generic ranitidine products due to possible NDMA contamination.
  • On October 23, 2019, Dr. Reddy’s Laboratories, Inc. announced it was voluntarily recalling all generic ranitidine products it sold in the U.S. due to unsafe levels of NDMA. These products were sold under its own label and the Walmart, Walgreens, and Kroger labels, among others.
  • On October 25, 2019, Lannett Company, Inc., announced a voluntary recall of its Ranitidine Syrup 15 mg/ml due to unsafe levels of NDMA.
  • On October 25, 2019, Novitium Pharma announced a voluntary recall of its Ranitidine Hydrochloride Capsules 150 mg and 300 mg due to potential NDMA contamination.
  • On November 6, 2019, Aurobindo Pharma USA announced a voluntary recall of one lot of Ranitidine Tablets 150 mg and 37 lots of Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg, and Ranitidine Syrup 15 mg/mL due to NDMA contamination.
  • On November 8, 2019, American Health Packaging announced a voluntary recall of eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups due to unsafe levels of NDMA. These products incorporated Ranitidine Syrup recalled by Lannett Company, Inc.
  • On November 8, 2019, Amneal Pharmaceuticals, LLC, announced a voluntary recall of its Ranitidine Tablets 150 mg and 300 mg and Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL due to potential NDMA contamination.
  • On November 15, 2019, Golden State Medical Supply, Inc., announced a voluntary recall of all unexpired lots of its Ranitidine HCl 150 mg and 300 mg Capsules due to potential NDMA contamination. These products had been manufactured and recalled by Novitium Pharma.
  • On November 19, 2019, Precision Dose, Inc., announced a voluntary recall of five lots of Ranitidine Oral Solution, USP 150 mg/10 mL due to potential NDMA contamination. These products had been manufactured and recalled by Amneal Pharmaceuticals, LLC.
  • On December 17, 2019, Glenmark Pharmaceuticals Inc., USA, announced a voluntary recall of all unexpired lots of its Ranitidine Tablets 150 mg and 300 mg due to potential or actual NDMA contamination.
  • On January 6, 2020, Denton Pharma, Inc., announced a voluntary recall of all unexpired lots of its Northwind label Ranitidine Tablets 150 mg and 300 mg in response to the recall by the manufacturer Glenmark Pharmaceuticals.
  • On January 7, 2020, Appco Pharma LLC announced a voluntary recall of all unexpired lots of Ranitidine Hydrochloride Capsules 150 mg and 300 mg due to actual or potential NDMA contamination.

During its investigation, the FDA announced it had found levels of NDMA in some products above the 96 nanogram daily limit the FDA considers “reasonably safe for human ingestion based on lifetime exposure.” The FDA advises companies to recall ranitidine products with higher NDMA levels and has also emphasized that, whatever the level of additional risk, the “presence [of NDMA and other nitrosamine contaminants] in drug products is not acceptable.”

 Consult your doctor before stopping any prescribed medication.
  

End Notes

  1. NDMA is the abbreviation for the chemical N-nitrosodimethylamine (chemical formula: C2H6N2O). NDMA is an organic (carbon-based) chemical that can form naturally as well as during industrial processes. NDMA was once used to help make liquid rocket fuel, antioxidants, additives for lubricants, and softeners for plastics. NDMA is no longer commercially used in the United States.
  2. The EPA has identified NDMA as “a drinking water contaminant of concern because of its miscibility with water [fully soluble in all proportions] as well as its carcinogenicity and toxicity.” The EPA also includes NDMA on the list of “extremely hazardous substances” it created as required by federal law.
  3. Ranitidine hydrochloride (commonly called ranitidine) is the generic name for a complex molecule with the chemical formula C13H23ClN4O3S. Ranitidine is the active ingredient in Zantac and its generic competitors; the drug treats heartburn by reducing production of stomach acid.

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