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Aero Healthcare: Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for A

DrugsSource: FDA (drug) · Date: 2025-11-12

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Aero Healthcare
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 / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-10-17
Code info
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Valley Cottage
State
NY
Country
United States
Event id
97809
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