Recall of Metformin Hydrochloride Extended-Release Tablets

On October 2, 2020, drug company Marksans Pharma Limited, India voluntarily expanded an earlier recall of metformin extended-release (ER) tablets (500 mg and 750 mg). The new recall includes 76 more lots of unexpired tablets. The first recall was on June 5, 2020.¹

Metformin ER tablets are a widely used prescription drug. Metformin, along with diet and exercise, improves blood sugar in people with type 2 diabetes.¹

Why was metformin ER recalled?

When Marksans Pharma Limited tested batches of metformin, the medicine contained too much of a contaminant called NDMA (N-Nitrosodimethylamine). Although the drug company has not received reports of problems associated with its metformin ER, it voluntarily recalled the products out of “an abundance of caution.”¹

What is NDMA?

NDMA is classified as a probable human carcinogen. This means that it can cause cancer. NDMA is an environmental contaminant found in water and foods like meats, dairy, and vegetables. During testing, NDMA levels in some lots of the drug company’s metformin ER tablets exceeded the acceptable daily intake limit of 96 mg per day.¹

The U.S. Food and Drug Administration (FDA) does not know how long people who take metformin ER may have been exposed to higher NDMA levels. The FDA states that these impurities may increase cancer risk over a long time. The agency does not expect shorter-term exposure to cause an increased risk of cancer. The FDA is working to make certain that drugs in the United States do not exceed the acceptable NDMA intake limit.²

Is my metformin prescription affected?

So far, 11 companies have recalled metformin ER. The FDA website has the full list of recalled metformin ER products. The list is current as of October 5, 2020. More information about drug recalls is available on the FDA drug recall page.

If you are not sure if your prescription is affected by the recall, contact your pharmacist for more information.

If my prescription is affected, what should I do now?

There are a few options:

• Contact your pharmacist and ask if the pharmacy stocks metformin from a drug company that is not affected by the recalls. If so, the pharmacist can refill your prescription with an unaffected lot. You can return your recalled medicine to the pharmacist when you pick up your new prescription.
• Talk to your doctor. Your doctor may want you to switch to the immediate-release type of metformin. Because it is not long-acting like the ER version, the immediate-release metformin usually requires twice-daily dosing. As of now, the FDA has not found NDMA in immediate-release metformin.^1,2

The FDA recommends that if you are taking an affected metformin ER product, you should not stop taking it abruptly. The FDA recommends that you continue taking it until your pharmacist replaces your medicine or your doctor prescribes an alternative. It is dangerous to stop taking metformin without talking to your doctor first.¹

In addition to the steps listed above, you can visit the FDA’s MedWatch website to report problems with your medicine.