Why is Zantac (Ranitidine) being Recalled?

In June 2019, the pharmacy company Valisure alerted the US Food and Drug Administration (FDA) that they found concerning levels of a possible carcinogen in ranitidine (the generic form of Zantac) during routine testing. Valisure proceeded to petition the FDA 3 months later to issue a recall and stop sales. Regulators soon followed by stating they’d review the safety of ranitidine, while Novartis generic drug manufacturing halted distribution of their versions of Zantac, and CVS and other pharmacies removed the product in their stores.

While the FDA has not issued an official recall, they stated in October 2019 that they were ordering all Zantac manufacturers to conduct testing for the suspected carcinogen N-nitrosodimethlylamine (NDMA). Additionally, a large number of companies including the primary manufacturers of the drug (Apotex, Sandoz/Novartis, and GlaxoSmithKline) have recalled the products after the Valisure petition was filed.

NDMA has been a known cancer risk for decades; an article from the 1970’s stated that “NDMA has caused cancer in nearly every laboratory animal tested so far.” In fact, its main use today is to induce tumor growth in experimental animals during laboratory research. NDMA can be produced naturally and artificially, and was formerly used in production of rocket fuel, lubricant additives, and plastics. It is classified as a probable carcinogen by the FDA, Environmental Protection Agency (EPA), World Health Organization (WHO), and the International Agency for Research on Cancer (IARC).

Blood pressure medications such as valsartan, losartan and irbesartan were recalled in 2018 due to “trace levels” of the same suspected carcinogen. The preliminary testing of ranitidine showed NDMA levels greater than 3 million nanograms per tablet, significantly more than trace amounts and far exceeding the FDA’s allowable daily intake of 96 nanograms.

Further, the NDMA found in these blood pressure medications formed due to a new manufacturing process. Contrastingly, research indicates that the NDMA apparent in Zantac samples comes from the instability of its own molecular structure. The ranitidine molecule has both a nitrate and dimethylamine (DMA) group, and can easily break down and essentially “react with itself” to form NDMA. This process occurs more readily in higher heat conditions, though no temperature label/regulation was ever placed on ranitidine drug products. Research also demonstrates that ranitidine forms significant amounts of NDMA with nitrate present. Shockingly, Zantac has been specifically marketed to treat symptoms caused by foods with high nitrate levels such as tacos, hot dogs, and pizza.

How Can We Help?

As Zantac was first introduced to the market in 1983 and became one of the best-selling drugs in its category, there have been many people taking it for many years. If you or a loved one has developed cancer after using Zantac (ranitidine), you aren’t alone. Our dedicated attorneys have experience representing clients in mass tort cases (when a civil wrong is committed by a person, entity, or group which results in injury to many victims).

By filing/joining a mass tort claim against Zantac, you may be able to get compensation for your damages and protect others from future threats. Our attorneys will be by your side to help you navigate this complex process with ease.

Don’t hesitate to pursue the compensation you deserve to make up for these pharmaceutical companies’ mistakes. Contact us today to schedule a free consultation and learn your rights.

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