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Class II · ModerateActive recall

Aerotab Pain Reliever

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAero Healthcare
Brand nameAEROTAB PAIN RELIEVER
Generic namePAIN RELIEVER
Active ingredient(s)ASPIRIN, CAFFEINE
Distributed by / forAERO HEALTHCARE US, Valley-Cottage, NY, 10989
NDC55305-135-01
Show the full FDA record
Full product labelAcetaminophen 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 firmAero Healthcare
DistributionUS Nationwide.
QuantityN/A
Recall initiated2025-10-17
Report date2025-11-12
Recall completed
Recall numberD-0155-2026
ClassificationClass II
FDA statusOngoing
Origin on fileValley Cottage NY United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.