WhichRecall
Class IIReported 2025-11-12

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

Recalled by Aero Healthcare

Reason for Recall

Labeling: Label Mix-up

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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.

Recall Number
D-0155-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-17
Reported
2025-11-12
Distribution
US Nationwide.
Code Info
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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