D-0155-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2025
- Initiation Date
- October 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
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 Pattern
US Nationwide.
Code Information
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01