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Zantac recall facts

On Behalf of | Aug 31, 2020 | Mass Tort Litigation |

Zantac is a medication designed to treat heartburn and indigestion in non-prescription form while treating acidic conditions and ulcers in the stomach with a prescription. Made by the European company GlaxoSmithKline, it became the first medication to profit $1 billion. However, some top sellers of Zantac in North Carolina and other states removed the medication after the FDA warned of carcinogens in ranitidine hydrochloride, a substance used in heartburn medication, although there was no official recall.


Laboratory experiments conducted by the FDA found that Nitrosodimethylamine, or NDMA, poses health risks. Known as a carcinogen since the 1970s, it caused cancer when tested in animals. This substance can be found in most foods in trace amounts.

The CDC issued warnings on small doses of NDMA, but the FDA concluded that low doses of 96 nanograms would not cause harm. However, research by the online drug company Valisure found that Zantac has over 2.5 million nanograms of NDMA, which caused a need for investigation.

The FDA didn’t arrive at that amount of NDMA during initial research but soon found that Valisure’s results had proven warranted. The FDA issued a statement saying its goal is to ensure that Americans have safe medication. While the organization didn’t find the same levels, it determined that Zantac should not be publicly available until quality becomes safer.


The FDA suggested consumers stop using Zantac in September 2019, and the organization issued an official Zantac recall in April 2020. Some pharmaceuticals had already removed the drug prior to the FDA sending letters to the drug companies that used ranitidine hydrochloride to remove products from shelves. Canada, France and 22 other countries banned the substance until further investigation.

Users of Zantac who have been diagnosed with cancer after using the product might be entitled to compensation. A lawyer with knowledge of mass tort lawsuits may be able to help with litigation.