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.

The decision was made due to a label mix-up that “affects the outer box labeling only,” the notice said.

The box incorrectly states that the pills have 500 milligrams of acetaminophen and 65 milligrams of caffeine, the notice added. The inner pouch correctly states that the caplets contain 500 milligrams of Aspirin (NSAID) with 32.5 milligrams of caffeine, it said.

The product has two caplets per packet, which come in a 50-count box, officials added. They were distributed nationwide, said the notice, which did not say how many packages were recalled.

One of the lots has a lot code 9282 and an expiration date of Sept. 1, 2026, while the other lot has a lot code of 9310 and an expiration date of Nov. 1, 2026.

Separate Recall of Tylenol Over Defective Container

In a separate notice issued this past week, the FDA said that 3,816 bottles of Tylenol Extra Strength were recalled on Oct. 21, and the FDA later classified the recall as Class II on Oct. 28. It involved a defective container, according to the notice, which provided no more details.

The recall was initiated by pharmaceutical giant Johnson & Johnson Consumer Inc. Each caplet contains 500 milligrams of acetaminophen, the notice said.

The recalled Tylenol products have a lot code of EJA022 and an expiration date of April 30, 2028.

While the products were distributed nationwide, the FDA report specifically mentioned Colorado, Indiana, Illinois, and Ohio.

A Class II recall is described by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Neither the FDA nor the companies provided specific instructions to consumers.

The recall comes as consumer goods giant Kimberly-Clark said it would pay $40 billion to purchase Tylenol maker Kenvue, a former division of Johnson & Johnson. This comes as the White House released data linking pregnant women’s use of acetaminophen, the active ingredient in Tylenol, to autism and attention-deficit hyperactivity disorder (ADHD) in children.

“The causative association ... between Tylenol given in pregnancy and the perinatal periods is not sufficient to say it definitely causes autism,” Health Secretary Robert F. Kennedy Jr. told reporters late last month, citing studies. “But it is very suggestive. There should be a cautious approach to it.”

Meanwhile, Kenvue has repeatedly defended the pain medicine, saying there is no scientific link to autism and warning that such suggestions could endanger maternal health.

Reuters contributed to this report.