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Recall Observatory FDA recall evidence

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

D-0155-2026

October 17, 2025

Class II

Product summary

Firm
Aero Healthcare
Event
Event 97809
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0155-2026

Official wording

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.

Code information: Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01

Distribution pattern: US Nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-up