February 27, 2020 Important update: new recall of certain lots of metformin tablets

This is an update to a previous statement regarding a recall of metformin tablets in Canada.

As a result of its recent product analysis, Ranbaxy Pharmaceuticals Canada Inc. is recalling six lots of its prescription RAN-Metformin drug from the Canadian market due to findings of nitrosamine impurity called N-nitrosodimethylamine (NDMA). After product testing, two lots (#AJY8006A and #AJY8007A) had NDMA levels above what is considered acceptable if the drug were to be taken over a lifetime. The company is also recalling an additional four lots (#AJY8005A, #AJY8005B, #AJY8008A and #AJZ8005A) as a precautionary measure because they contain NDMA close to the acceptable limit.

Earlier this month Apotex Inc. announced a recall of certain lots of its 500 mg extended release metformin tablets (“APO-Metformin ER”) because they contain NDMA above the acceptable limit.

As noted in Health Canada’s statement: “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.”

Given the wide-spread use of metformin, many Canadians may have concerns about the safety of their metformin medication. “We understand this news may be unsettling for all those who rely on metformin to manage their condition,” says Seema Nagpal, vice-president of Science & Policy with Diabetes Canada. “We advise all patients who manage their diabetes with metformin to continue their treatment regimen and to work with their health-care provider to discuss concerns.”

The contaminated products from both companies are being removed from pharmacies, so no patients receive them in the future.

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.

Health Canada advised that testing by several other Canadian manufacturers is still currently underway to determine whether any other metformin products may be affected.

“We understand there are more companies currently testing their metformin products that have yet to provide their results and we urge Health Canada to expedite this process,” says Nagpal.

Diabetes Canada will continue to provide updates through our newsroom and social media channels.  An updated list of affected products is in the table below.