Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB
Summary
The FDA issued a Class II for Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet furt by Aero Healthcare. Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65.
Details
Source
Drug Recall
External ID
D-0155-2026
Action Date
2025-11-12
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Quantity Affected: N/A
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-17
Company
Valley Cottage, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aero Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aero Healthcare have FDA actions?
This is the only FDA action we have on record for Aero Healthcare in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0155-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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