FDA: More than 140,000 Bottles of Generic Cholesterol Drug Recalled

Over 140,000 bottles of a cholesterol medication are the subject of a recall, the U.S. Food and Drug Administration (FDA) said.

The issue surrounds “failed dissolution specifications” linked to the Atorvastatin Calcium Tablets, Fox Business reported on Friday.

The outlet said there are several bottle sizes of the 10 mg medication being recalled. According to the Mayo Clinic, the drug is used along with diet to lower a patient’s cholesterol and ward off heart attacks or strokes.

“Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins,” the site reads. “It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. This medicine is available only with your doctor’s prescription.”

The medication is the generic form of Lipitor, the Fox article noted.

It continued:

If a medication has “failed dissolution specifications,” it means the drug did not dissolve in laboratory testing the way it is supposed to according to official standards. If a pill doesn’t dissolve the way it should, the medicine might not work as effectively to control cholesterol levels.

The alert is considered a Class II recall, which is when the use or exposure to a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA’s website.

Fox identified the manufacturer as Alkem Laboratories and the distributor is Ascend Laboratories LLC.

“There are eight lot numbers impacted with expiration dates ranging between July 2026 to February 2027. The bottle sizes included 90 tablets, 500 tablets and 1,000 tablets,” the article stated.

Per the Mayo Clinic, high levels of cholesterol in a person’s blood can increase their risk for heart disease, and although it can be inherited, some people experience high cholesterol due to a poor diet, eating a lot of saturated fats, or not getting enough exercise.

“You can make changes to help prevent it. And if you have high cholesterol, you can help lower it with a healthy diet, regular exercise and sometimes medicine,” the site reads.

According to Johns Hopkins Medicine, more than 70 million Americans suffer from high cholesterol.