Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets
- Recalling company
- Aero Healthcare
- 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
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 17, 2025
- Reported
- Nov 12, 2025
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
- Company location
- Valley Cottage, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0155-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0155-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.