In ongoing lawsuits in the USA, claims have been made that Zantac and ranitidine contain unacceptable levels of the cancer-causing chemical N-Nitrosodimethylamine, or NDMA. Lawyers have charged that NDMA contamination causes stomach, liver, and bladder cancer. In September 2019, an online pharmacy had alerted the U.S. Food and Drug Administration that it \u201cdetected extremely high levels of NDMA, a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.\u201d A report by the World Health Organization Organs says that NDMA could potentially affect the bladder, brain, liver, kidneys, lungs and stomach.<\/p>\n
While the FDA has determined that daily intake of NDMA should not exceed 96 nanograms \u2014 one billionth of a gram, the pharmacy found 2,511,469 ng of NDMA in Zantac OTC and 3,267,968 ng of NDMA in Zantac Cool Mint. The FDA said that although the pharmacy\u2019s method of high-temperature testing may have increased the levels of NDMA in samples, it still reported unacceptable levels of the contaminant after \u201cearly, limited testing\u201d using a low-heat method. New testing found that NDMA levels in ranitidine may rise above the acceptable limit even when it\u2019s stored under normal conditions, and that the longer the length of time since the time of manufacture, the greater the level of NDMA.<\/p>\n
On April 1, 2020, the FDA asked manufacturers of all ranitidine products to remove prescription and over-the-counter ranitidine drugs from the market. The agency said, \u201cAlthough there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.\u201d Retailers removed formulas of Zantac from their shelves, while 14 generic manufacturers and Sanofi , Zantac\u2019s manufacturer, recalled the drug in the United States. The lawsuits claim that Sanofi and other manufacturers knew about the dangers of NDMA but failed to properly warn the public.<\/p>\n