FDA Issues Notice in Recall of More Than 140,000 Bottles of Common Statin Medication

Several versions of generic atorvastatin calcium tablets are under recall, the agency says.

The logo of the U.S. Food and Drug Administration (FDA) is seen on a sign outside the agency's White Oak campus in Silver Spring, Maryland., on July 17, 2025. Issam Ahmed/AFP via Getty Images

The Food and Drug Administration (FDA) recently said that it issued a Class II classification notice to a recall of at least 140,000 bottles of the generic version of atorvastatin, a commonly used drug prescribed to treat cholesterol and heart issues.

In a notice issued on Oct. 10, the agency said that several versions of generic atorvastatin calcium tablets are under recall because of failed dissolution specifications, indicating the drug did not dissolve at the expected rate under FDA guidelines. This means that a patient may not be able to absorb the medication properly, according to the FDA.

The brand-name version of atorvastatin, Lipitor, is not subject to the recall.

The generic 10-milligram atorvastatin tablets under recall were sold in 90-count, 500-count, and 1,000-count bottles. They were made by Alkem Laboratories, Ltd., based in India, and distributed by New Jersey-based Ascend Laboratories LLC, the FDA said.

Several versions of the drug were named in the recall, including 20-milligram, 40-milligram, and 80-milligram doses sold in 500-count and 1,000-count bottles. The FDA recall notice did not list how many bottles were recalled.

The FDA’s Class II designation indicates that exposure or usage of “a violative 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.

The notice did not list whether there were any injuries or adverse events associated with the medication under recall.

Atorvastatin is taken to lower high cholesterol levels in the blood, according to the government-run MedlinePlus website. The medication is a member of the statin family, which blocks the body’s production of cholesterol in the liver.

The drug is also used to help prevent such health problems as chest pain, stroke, or heart attack caused by cholesterol clogging blood vessels, according to the Mayo Clinic. It can also be used to treat certain forms of “heart and blood vessel problems in patients with risk factors for heart problems,” the clinic stated.

In 2024, Yale University released data suggesting that 47 million Americans take a cholesterol medication each day, including statins.

Atorvastatin has been one of the most prescribed drugs in the United States in recent years. The ClinCalc database shows that as of 2023, it was the No. 1 drug being taken in the country, with around 29 million patients and 115 million yearly prescriptions.

The FDA last year issued a citation to Alkem Laboratories after inspections revealed broken equipment, unsanitary conditions, incomplete records, and other problems.

In August, the FDA confirmed recalls of tens of thousands of bottles of two different types of blood pressure and heart medications due to the presence of cancer-linked organic compounds known as nitrosamines. At the time, the FDA confirmed the recall of 88,032 bottles of carvedilol tablets and 20,000 bottles of metoprolol tartrate tablets, both used to treat high blood pressure and heart failure.

The metoprolol was produced by Nashville-based Westminster Pharmaceuticals LLC at a facility operated by Renata PLC in Bangladesh, and the carvedilol was produced by New Jersey-based Glenmark Pharmaceuticals Ltd. at a factory in Goa, India, according to the agency, which classified those recalls as Class II.