Recalls / Class II
Class IID-0155-2026
Product
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
- Brand name
- Aerotab Pain Reliever
- Generic name
- Pain Reliever
- Active ingredients
- Aspirin, Caffeine
- Route
- Oral
- NDC
- 55305-135
- FDA application
- M013
- Affected lot / code info
- Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Why it was 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.
Recalling firm
- Firm
- Aero Healthcare
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 616 Corporate Way Ste 6, N/A, Valley Cottage, New York 10989-2047
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-10-17
- FDA classified
- 2025-11-05
- Posted by FDA
- 2025-11-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0155-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.