FDA Drugs recall ·

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each… recall

Recall number
D-0121-2026
Date
(initiated October 21, 2025)
Company / brand
Kenvue Brands LLC
1 Kenvue Way, Summitt, NJ, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
3,816 bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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.

Why was it recalled?

Defective Container

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot: EJA022, expiry: 04/30/2028

Distribution

U.S. Nationwide - CO, IL, OH and IN.

States: Colorado Illinois Indiana Ohio

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0121-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.