FDAFDA · Food and drugs·Recall number D-0155-2026
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
Published November 12, 2025 · Recall initiated: October 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- AEROTAB PAIN RELIEVER
- Manufacturer
- Aero Healthcare
- Distributor
- US Nationwide.
- Lot
- Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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