Class IIOngoing

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

FDA recall D-0121-2026 · initiated Oct 21, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Defective Container

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

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0121-2026 ↗

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