US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 21, 2025 (11 months ago)

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson &…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Container

What was recalled

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 firm
Kenvue Brands LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0121-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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