Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets You should not stop taking your medication without first discussing treatment options with your health care provider. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of nitrosamines found in the recalled Apotex metformin products. Apotex Inc. is recalling eight lots of its 500 mg extended release metformin tablets ("APO-Metformin ER") because they contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets; only the affected lots are being recalled (see table below). There are also alternative metformin products on the Canadian market manufactured by other companies. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Individuals taking metformin, including a recalled product, should not stop taking it unless they have spoken to their health care provider as the risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products. NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer. In December 2019, Health Canada communicated that it is assessing the issue of NDMA in metformin products, after some metformin products available outside Canada were detected to contain NDMA above the acceptable limit. The Department asked companies to test their metformin products and is conducting testing in its own laboratories. Health Canada is also working closely with international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to inform its assessment. Health Canada continues to assess this issue, and will update the table below and inform Canadians should any additional recalls be necessary. Health Canada has been working to address the issue of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners to address the issue. The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information.
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