TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson &… recall
FDA recall D-0121-2026 · initiated Oct 21, 2025
Kenvue Brands LLC recalled TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… in Oct 2025 — an FDA Class II recall (D-0121-2026) because Defective Container.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container
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: 3,816 bottles
Details
- Product
- TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
- Recalling company
- Kenvue Brands
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide - CO, IL, OH and IN.
- Initiated
- Oct 21, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… recalled?
- Kenvue Brands LLC recalled TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… in Oct 2025 — an FDA Class II recall (D-0121-2026) because Defective Container. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… recalled?
- Per the FDA enforcement record, the reason for recall D-0121-2026 was: Defective Container
- Is a recalled TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… 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 TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:… are affected?
- Distributed: U.S. Nationwide - CO, IL, OH and IN.. The recall covers these lots — Lot: EJA022, expiry: 04/30/2028. 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-0121-2026.