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Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a...

FDA Recall #D-0155-2026 — Class II — October 17, 2025

Recall #D-0155-2026 Date: October 17, 2025 Classification: Class II Status: Ongoing

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

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.

Recalling Firm

Aero Healthcare — Valley Cottage, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

US Nationwide.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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