Reported Nov 12, 2025 · Ongoing
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO…
Aero Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aero Healthcare · 616 Corporate Way Ste 6 · Valley Cottage, NY · 10989-2047
Is this the product you have?
- 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
- Lot codes and dates
- Lot # 9282
- Exp Date
2026-09-01Lot # 9310
- Exp Date2026-11-01
- Amount recalled
- N/A
Where it was sold
- 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.
This product could cause temporary or reversible health problems — stop using it.
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