Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TA…

Recall date

October 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0155-2026

FDA classification

Class II

Brand / firm

Aero Healthcare

Sold / distributed

US Nationwide.

Why it was recalled

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01