FDA Drug · 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 AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

Class II · Ongoing

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.

Affected lots / codes — check yours against thisLot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01

Recalling firm: Aero Healthcare, Valley Cottage, NY
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: N/A
Distribution: US Nationwide.
Recall initiated: October 17, 2025
Classified: November 5, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0155-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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