Acetaminophen 500mg Caffeine 65mg caplets
Recalled by Aero Healthcare
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Aero Healthcare has recalled Acetaminophen 500mg Caffeine 65mg caplets, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 12, 2025 and was initiated on October 17, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Acetaminophen 500mg Caffeine 65mg caplets, with approximately N/A affected. The company behind the recall is Aero Healthcare, based in Valley Cottage, NY. The FDA describes the product as: “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”
Why was Acetaminophen 500mg Caffeine 65mg caplets recalled?
According to the FDA, the stated reason for the recall is: “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 should you do?
If you think you may have bought Acetaminophen 500mg Caffeine 65mg caplets, compare it against the product description and identifying codes (Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Aero Healthcare or your local health authority.
About this recall
This recall was distributed in NY. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- November 12, 2025
- Recall started
- October 17, 2025
- Distributed in
- NY
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Acetaminophen 500mg Caffeine 65mg caplets recalled?+
According to the FDA: Labeling: Label Mix-up.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Acetaminophen 500mg Caffeine 65mg caplets?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0155-2026. Information last synced from the FDA on July 6, 2026.