FDA Drug recall D-0155-2026
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for… by Aero Healthcare, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0155-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aero Healthcare |
| Distribution | US |
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.
Identifiers
| ndc | 55305-135-01 |
|---|---|
| ndc | 55305-135-02 |
| ndc | 55305-135-03 |
| code_info | Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0155-2026%22
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