Could cause temporary or reversible harm; serious harm is unlikely.
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.
| Brand name | AEROTAB PAIN RELIEVER |
| Generic name | PAIN RELIEVER |
| Active ingredient(s) | ASPIRIN, CAFFEINE |
| Distributed by / for | AERO HEALTHCARE US, Valley-Cottage, NY, 10989 |
| NDC | 55305-135-01 |
| Full product label | 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 |
| Recalling firm | Aero Healthcare |
| Distribution | US Nationwide. |
| Quantity | N/A |
| Recall initiated | 2025-10-17 |
| Report date | 2025-11-12 |
| Recall completed | — |
| Recall number | D-0155-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Valley Cottage NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗