FDA recall D-0155-2026

Aero Healthcare · Class II · drug

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.

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-10-17
Report date: 2025-11-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Valley Cottage, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2026