Drug recall D-0155-2026

Class II Ongoing reported Nov 12, 2025

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 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.

Lots and codes

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

Recall details

Recalling firm
Aero Healthcare, Valley Cottage, NY
Quantity
N/A
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
October 17, 2025

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