Aero Healthcare: Drug Recall
Recall #D-0155-2026 · 10/17/2025
Class II: Risk
Recall Details
- Recall Number
- D-0155-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Aero Healthcare
- Status
- Ongoing
- Date Initiated
- 10/17/2025
- Location
- Valley Cottage, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Product Description
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
Distribution Pattern
US Nationwide.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.