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

FDA Recall #D-0121-2026 — Class II — October 21, 2025

Recall #D-0121-2026 Date: October 21, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Reason for Recall

Defective Container

Recalling Firm

Kenvue Brands LLC — Summitt, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,816 bottles

Distribution

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

Code Information

Lot: EJA022, expiry: 04/30/2028

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated