Nearly 7,000 Bottles of a Heart and Diabetes Medication Recalled in At Least One State

Right now,  the Mayo Clinic suggests more than 150 million people around the world rely on metformin, making it one of the most common prescriptions on the market. However, a recent recall affecting 6,804 bottles of metformin means some of the 20 million Americans on metformin will want to check their supplies.

Metformin is most often used alongside diet and exercise as a means of stabilizing blood sugar levels in those with Type 2 diabetes. Additionally, the medication is sometimes used to treat various heart conditions and their risk factors, including heart failure, coronary heart disease, atherosclerosis, and more.

Triggering the recall, the FDA has reported a consumer discovered that their 1000-count bottle of Metformin Hydrochloride Extended-Release Tablets contained foreign capsules—specifically, a 500-milligram (mg) tablet of the pain reliever paracetamol, also known as acetaminophen. Paracetamol is the generic name for the brands Tylenol, Dymadon, Lemsip, Panadol, and Panamax.

Now, the U.S. Food and Drug Administration (FDA) has designated the recall a Class II risk level, calling it “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

There are several ways that undeclared paracetamol may cause adverse effects in consumers, which could range from mild to severe. In cases of serious allergy, it is possible for exposure to the medication to cause anaphylaxis. Those with liver or kidney problems, and those who drink more than 14 units of alcohol per week, should also avoid paracetamol, health authorities suggest.

Another concern is that if consumers unknowingly take a paracetamol tablet from the bottle, they will have skipped their prescribed dose of metformin. The Mayo Clinic says that this type of mix-up could result in a temporary spike in blood sugar among diabetic patients.

The affected drugs were produced by Granules Pharmaceuticals Inc., a Chantilly, VA based company, and manufactured in Hyderabad, India. They were then sent to a distributor in Ohio, though it is unclear whether other states may also be implicated in the recall.

To determine whether you have the affected products in your possession, look for the following identifying information on 1000-count bottles of 500-milligram (mg) tablets:

• Lot Number: 4911311A
• Exp. Date: November 2025

If you do in fact have the affected drugs at home, call your doctor or pharmacist to discuss how you can safely replace your supply without missing any doses.

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