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Drug FDA Class II Ongoing Mislabeling

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

Aero Healthcare Published Nov 12, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Aero Healthcare or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Outer box label states incorrect active ingredients (Acetaminophen 500mg and Caffeine 65mg instead of Aspirin 500mg and Caffeine 32.5mg) · primary

Affected products (1)

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

AEROTAB PAIN RELIEVER · N/A

NDC: 55305-135, 55305-135-01, 55305-135-02, 55305-135-03
Lot codes: 9282, 9310
Code info: Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 17, 2025
  2. Published
    Nov 12, 2025
Recall number
D-0155-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.