Acetaminophen 500mg Caffeine 65mg caplets — Class II drug recall D-0155-2026
Ongoing recall by Aero Healthcare, reported 2025-11-12, distributed nationwide. Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredi
| Recall number | D-0155-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aero Healthcare, Valley Cottage, NY, United States |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-05 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 55305-0135, 55305-0135-01, 55305-0135-02, 55305-0135-03 |
| Lot numbers | 9282, 9310 |
| Expiration dates | 2026-09-01, 2026-11-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0155-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.