Cholesterol medication recalled over 'failed dissolution specifications': What to know

(NEXSTAR) – Over 141,000 bottles of cholesterol medication have been recalled due to “failed dissolution specifications,” suggesting that the drugs did not pass a solubility test, or failed to dissolve at a standard rate.

Ascend Laboratories, LLC, a New Jersey-based pharmaceutical company, first initiated its recall of the atorvastatin calcium tablets on Sept. 19, 2025, according to an enforcement report from the U.S. Food and Drug Administration.

This month, the recalled drugs were categorized under a “Class II” recall, meaning health officials believe that the use of the affected 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 recall currently only affects bottles of 10mg, 20mg, 40mg and 80mg atorvastatin calcium tablets manufactured by Alkem Laboratories, Ltd., of India, and distributed by Ascend. The recalled bottles contained different quantities of the tablets, ranging from 90-count to 1000-count bottles. Just under 142,000 bottles of the 10mg medication were involved in the recall; the quantity of recalled bottles containing 20mg, 40mg and 80mg tablets was listed in the FDA’s enforcement report.

More specific information on the recalled medication, including lot codes and expiration dates, is available in the report.

A representative for Ascend Laboratories, LLC, was not immediately available to comment or to provide information for consumers who have any of the recalled medication in their possession. The FDA urges speaking with a doctor or pharmacist, but explains that "consumers can generally continue taking the medicine unless the recalling company provides other instructions."

“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” the FDA says.

Atorvastatin calcium is a drug used to control cholesterol levels and help prevent heart attacks or strokes, per the National Institutes of Health. The most common brand name of atorvastatin calcium tablets is Lipitor, a drug manufactured by Pfizer. In 2023, Harvard Health estimated that more than 40 million Americans are prescribed statins, making them “the most prescribed” drug in the country.