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.
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
Lot numbers, UPCs & expiration codes
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0155-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 17, 2025
- FDA report date
- Nov 12, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aero Healthcare
Original FDA data
Every field from FDA enforcement report D-0155-2026, exactly as published.
Show all FDA fields
- City
- Valley Cottage
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97809
- Address
- 616 Corporate Way Ste 6
- Code information
- Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
- Postal code
- 10989-2047
- Report date
- Nov 12, 2025
- Product type
- Drugs
- Recall number
- D-0155-2026
- Classification
- Class II
- Recalling firm
- Aero Healthcare
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Oct 17, 2025
- Initial firm notification
- Center classification date
- Nov 5, 2025