FDA Recalls 141,984 Atorvastatin Bottles Nationwide

The FDA announced a voluntary recall of at least 141,984 bottles of Atorvastatin Calcium after an enforcement report found “failed dissolution specifications,” meaning some tablets may not dissolve properly and could be less effective. The voluntary recall was initiated Sept. 19 and the action was classified as Class II on Oct. 10. The recall covers multiple strengths and bottle sizes — including 90-, 500- and 1,000-count bottles — manufactured by Alkem Laboratories (India) and distributed by Ascend Laboratories (New Jersey), with affected lot codes and expiration dates mostly between July 2026 and February 2027. A Class II classification indicates use may cause temporary or medically reversible adverse health consequences and that the probability of serious harm is remote. Consumers should check lot numbers and expiration dates, should not take bottles that match the recalled lots, and should contact their pharmacy or prescriber for replacement or refund; GoodRx and the FDA contact line have been cited for guidance, while Ascend and Alkem have not issued detailed public statements.