← FDA ENFORCEMENT
D-0155-2026Class II

Aero Healthcare

Recalling firm
Aero Healthcare
Product type
Drug
Status
Ongoing
Report date
2025-11-12
Distribution
US Nationwide.
Firm state
NY
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.