United StatesAero Healthcare is recalling AERO TAB outer-boxed 50-count boxes labeled “Acetaminophen 500mg Caffeine 65mg” (2 caplets per packet, NDC 55305-135-01), Lot #9282 (exp. 2026-09-01) and Lot #9310 (exp. 2026-11-01). The recall is due to a label mix-up: the outer box incorrectly lists Acetaminophen 500mg and Caffeine 65mg, while the inner pouch correctly lists Aspirin 500mg and Caffeine 32.5mg.
What's being 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
Recalling firm: Aero Healthcare, Valley Cottage, NY, United States.
How to identify it
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)