CLASS II ONGOING Drug recall · Reported 12 Nov 2025 · FDA Enforcement Report
Acetaminophen 500mg Caffeine 65mg caplets recalled by Aero Healthcare
Aero Healthcare is recalling Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet, distributed nationwide in the US. The recall was initiated on 17 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0155-2026
- FDA event ID
- 97809
- Recalling firm
- Aero Healthcare, Valley Cottage, NY
- Manufacturer
- Aero Healthcare
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2025
- FDA classified
- 5 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 17 Oct 2025 | Recall initiated by company | |
| 5 Nov 2025 | Classified by FDA | +19 days |
| 12 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Is Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet recalled?
Yes. Aero Healthcare recalled Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet on 17 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0155-2026.
Why was it 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.
Which lots are affected?
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.