Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIDrug recallOngoing

Acetaminophen recall

Recalled by Aero Healthcare of Valley Cottage, NY · FDA report 11/12/2025

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 10/17/2025
Distribution: Nationwide

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.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

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
Lot and code info: Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Brand names: AEROTAB PAIN RELIEVER
Recall number: D-0155-2026
Event ID: 97809
Initiated by: Voluntary: Firm initiated

Where it was distributed

US Nationwide.

Nationwide

Recall timeline

10/17/2025Firm started the recall
11/05/2025FDA classified it as Class II
11/12/2025Published in the FDA enforcement report

Frequently asked questions

Why was Acetaminophen recalled?: 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.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: US Nationwide.
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 11/12/2025 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Drug
Reported: 11/12/2025

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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