Nostrum Laboratories Voluntarily Recalls an Additional Lot of Extended Release Metformin

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and people who take metformin that Nostrum Laboratories has voluntarily recalled an additional lot of extended-release (ER) metformin. The drug has been recalled because it may contain an amount of N-nitrosodimethylamine (NDMA) above the acceptable intake limit.1

Metformin can be used, along with diet and exercise, to control high blood sugar in those living with type 2 diabetes. It is a prescription drug that lowers the amount of sugar the liver releases into the bloodstream.1

There have been several recalls of ER metformin from various laboratories in the last 6 months due to high levels of NDMA. More information about recalls is available on the FDA drug recall page.1,2

What is NDMA?

NDMA is an impurity found in some formulations of the extended-release version of metformin, but not the immediate-release (IR) version or in the active pharmaceutical ingredient. NDMA is an environmental contaminant and probable carcinogen, which means it may cause cancer when taken over a period of time. The acceptable intake limit of NDMA is 96 nanograms per day.2,3

If you have taken medicine with NDMA over the acceptable limit for a short amount of time, the FDA states that this is not expected to lead to an increased risk of cancer. It is the long-term consumption of increased NDMA that is worrisome.2,3

How is this different from other recalls?

While there have been previous recalls of other metformin batches, this particular recall is about an additional lot of the drug that Nostrom is voluntarily recalling. The FDA publishes a list of specific metformin products that are affected by the recall.

What does this mean for those taking metformin?

If you take ER metformin, call your pharmacist. Your metformin may be part of the lot that is being recalled.

Do not stop taking your metformin. People with type 2 diabetes can have serious health effects if they abruptly stop taking metformin. Call your pharmacist and find out if your refill has been affected. If it has, ask them if they have any metformin in stock that has not been affected by recalls and if your prescription can be refilled with that. You should bring your recalled medicine to the pharmacist, and they will dispose of it for you.

Talk with your doctor about what is going on with your prescription and whether immediate-release metformin might be a better option for you. Right now, the recalls have only included ER formulation of the drug.

If you are unable to get metformin that has not been affected by a recall, talk with your doctor about what they would like you to do. They may prescribe an alternative medicine.

You can also visit the FDA’s MedWatch website to report problems with your medicine.

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