Acetaminophen 500mg Caffeine 65mg caplets recall
FDA recall D-0155-2026 · initiated Oct 17, 2025
Aero Healthcare recalled Acetaminophen 500mg Caffeine 65mg caplets in Oct 2025 — an FDA Class II recall (D-0155-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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
- Recalling company
- Aero Healthcare
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Oct 17, 2025
- FDA report date
- Nov 12, 2025
Frequently asked
- Was Acetaminophen 500mg Caffeine 65mg caplets recalled?
- Aero Healthcare recalled Acetaminophen 500mg Caffeine 65mg caplets in Oct 2025 — an FDA Class II recall (D-0155-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Acetaminophen 500mg Caffeine 65mg caplets recalled?
- Per the FDA enforcement record, the reason for recall D-0155-2026 was: 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.
- Is a recalled Acetaminophen 500mg Caffeine 65mg caplets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen 500mg Caffeine 65mg caplets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0155-2026.