Class II
Ongoing
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
This recall is currently active, issued November 12, 2025. It was issued by Aero Healthcare.
- Company
- Aero Healthcare
- Recall Initiated
- October 17, 2025
- Posted
- November 12, 2025
- Recall Number
- D-0155-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Valley Cottage, NY, United States
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide.
Lot / Code Info
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
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