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Class II · ModerateActive recall

Tylenol Extra Strength

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: EJA022, expiry: 04/30/2028
Where it was soldU.S. Nationwide - CO, IL, OH and IN.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Container

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byKenvue Brands LLC
Brand nameTYLENOL EXTRA STRENGTH
Generic nameACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN
Distributed by / forJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034
NDC50580-378-04
Show the full FDA record
Full product labelTYLENOL, 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 firmKenvue Brands LLC
DistributionU.S. Nationwide - CO, IL, OH and IN.
Quantity3,816 bottles
Recall initiated2025-10-21
Report date2025-11-05
Recall completed—
Recall numberD-0121-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSummitt NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.