Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acetaminophen 500mg Caffeine 65mg caplets Recalled by Aero Healthcare Due to Labeling: Label Mix-up. This issue affects the outer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aero Healthcare directly.
Affected Products
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
Quantity: N/A
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aero Healthcare
Aero Healthcare has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report