The US Food and Drug Administration (FDA) has issued a recall of more than 140,000 bottles of Atorvastatin Calcium, a generic variant of Lipitor.
Ascend Laboratories of New Jersey started the recall on September 19, 2025, for tablets manufactured by Alkem Laboratories in India and distributed nationwide.
The affected lots include 10 mg, 20 mg, 40 mg, and 80 mg doses in 90-, 500-, and 1,000-count bottles, with an expiration date through February 2027.
The FDA classified the recall as Class II on October 10, 2025, indicating that the recalled products may have “temporary or medically reversible adverse health consequences.”
Atorvastatin is a reductase inhibitor, or statin that can help clear the bloodstream of cholesterol to prevent fat accumulation that leads to atherosclerosis.
Nearly 39 million U.S. adults take statins, majorly individuals above 40.
The FDA and Ascend Laboratories has not yet released the guidelines for steps to take with the recalled pills.
GoodRx has strongly recommended patients to check their medication’s lot number, contact their pharmacy or healthcare provider, and safely dispose of the affected products.
