Acetaminophen Recalled Nationwide Due to Labeling Mix-Up, FDA Says

A recall notice indicates that the caffeine-supplemented tablets distributed by Aero Healthcare US actually contain aspirin.

In this photo illustration, Acetaminophen is listed as an active ingredient on a bottle of medicine in San Anselmo, Calif., on Sept. 23, 2025. Justin Sullivan/Getty Images

Two lots of acetaminophen and caffeine have been recalled nationwide due to a labeling mix-up. The Food and Drug Administration (FDA) said this week that the pills actually contain aspirin.

An FDA notice said that New York-based Aero Healthcare US recalled caplets billed as containing 500 milligrams of acetaminophen and 65 milligrams of caffeine. The firm initiated the recall, which the FDA classified as Class II, on Oct. 17.