Metformin Recall: What to Do If This Affects You

On May 28, the Food and Drug Administration (FDA) announced that lab testing revealed higher than acceptable amounts of N-Nitrosodimethylamine (or NDMA) in several batches of metformin, one of the most popular prescription drugs used to control high blood sugar in people with type 2 diabetes.

In the months since the announcement, the FDA has notified seven pharmaceutical firms who manufacture metformin, recommending a recall of 102 products so far.

Which Types of Metformin Are Recalled?

The FDA recall only includes certain types of extended-release (or ER) metformin. It doesn’t apply to immediate-release (IR) metformin, which is the most commonly prescribed type. After testing, the FDA found low to non-detectable levels of NDMA in all IR metformin.

As of August 21, all seven pharmaceutical companies have followed the recall recommendation and pulled their ER Metformin tablets from the retail market:

• Amneal
• Apotex Corp.
• Teva Pharmaceuticals USA, Inc. (packaged under the Actavis Pharma Inc. label)
• Marksans Pharma Ltd. (packaged under Time-Cap Labs, Inc. label)
• Lupin Limited
• Granules Pharmaceuticals, Inc.
• Bayshore Pharmaceuticals, LLC

What Should You Do If Your Medication Was Recalled?

Jennifer Okemah, MS, RD, BCADM, CDCES, CSSD, a Certified Diabetes Educator and owner of diabetes and nutrition private practice Salute Nutrition, PLLC in Washington, tells Verywell through email that "the first step is to know for sure that your medication is the exact one that was recalled." She says, "if your metformin is not extended-release, you do not have to be concerned."

If you’re taking a recalled version of ER metformin, or if you're not sure your medication was recalled, don't stop taking it right away.

"Take your pill bottles to your pharmacy and find out if you’ve been taking drugs from one of the recalled lots," Nazirber De La Cruz, RDN, CDN, CDCES, a certified diabetes education specialist and director of nutrition at Elmhurst Digestive and Liver Diseases in Queens, NY, tells Verywell via email. "Pharmacists may be able to replace the same medication from a manufacturing lot that has not been recalled."

Janelle Langlais, RD, LD, CDE, an ADEPT-certified Diabetes Care and Education Specialist and Diabetes Educator at Wentworth-Douglass Hospital in Dover, New Hampshire tells Verywell via email that “Patients should ask their doctor about other treatment options, ask for a referral to a diabetes care and education specialist and/or registered dietitian to make individualized lifestyle changes and come up with a plan, and continue taking their medications until they discuss with their provider.”

Why Shouldn't You Stop Taking Metformin?

Metformin works by decreasing the amount of sugar your liver releases into your blood, making your body more sensitive to insulin’s effects. If you suddenly discontinue use, it can lead to dangerously high blood sugar levels. As a result, you may experience:

• Headache
• Difficulty concentrating
• Increased thirst and/or hunger
• Dry mouth
• Fatigue and drowsiness
• Blurred vision
• Bloating
• Dehydration
• Shortness of breath
• Coma/death

Okemah adds that "Chronic high blood sugars can cause damage to small blood vessels (think of the tiny ones in the eyes—the same ones make up blood supply to your kidneys) and large blood vessels."

Although immediate-release metformin is more commonly prescribed, Okemah says that extended-release forms are usually easier to tolerate. If your metformin was recalled and your doctor switches you to an immediate-release version, you may experience some side effects, like gas, bloating and diarrhea.

But according to Okemah, these are "mostly a transient side effect that can be annoying but resolvable." She encourages you to "talk to your doctor about ways to mitigate this if it happens. [And] Check your blood sugar!"

What Are the Health Effects of NDMA Exposure?

You’re likely exposed to some NDMA every day through the air around you or the water you drink. Okemah adds that nitrosamines like NDMA are also sometimes added to foods as preservatives. And while you probably don't realize if you’re exposed to low levels, symptoms of too much exposure can include:

• Headache
• Fever
• Nausea
• Jaundice
• Vomiting
• Abdominal cramps
• Dizziness
• Enlarged liver
• Reduced function of the liver, kidneys, and lungs

Because of studies that connected long-term NDMA exposure and certain types of cancer, the contaminant is also classified as a “probable human carcinogen” by the U.S. Department of Health and Human Services.

A Word From Verywell

Finding out your medication has been recalled can be alarming. But there's no need to panic. If you're taking one of the recalled brands of metformin, your doctor will work with you to figure out the best appropriate next steps. In addition to continuing with your medication as prescribed, it’s also important to keep following your doctor or nutritionist’s recommended diet plan for type 2 diabetes.