Class I Recall for OTC Pain Reliever

A Class I recall has been issued for 429 bottles of 500-mg acetaminophen extra-strength tablets because of a labeling error. According to the August 14, 2024, US Food and Drug Administration (FDA) Enforcement Report, some bottles were incorrectly labeled with the drug facts label for aspirin 81-mg tablets.

The Class I recall classification is the FDA’s most serious and communicates that use of the product could cause serious adverse health consequences or death.

The recall affects acetaminophen extra-strength tablets, 500 mg each, in 100-count bottles (NDC 50090-5313-2) from lot 4138197 (Exp. 10/31/25). The product was packaged by A-S Medication Solutions, Libertyville, Illinois, and distributed within the United States.

A-S Medication Solutions voluntarily initiated the recall on June 21, 2024. On August 8, 2024, the FDA issued its Class I designation.

Acetaminophen is an over-the-counter medication used to reduce fever and relieve minor aches and pains.