D-0121-2026Class II

Kenvue Brands LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Kenvue Brands LLC

Product type

Drug

Status

Ongoing

Report date

2025-11-05

Distribution

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

Firm state

Product quantity

3,816 bottles

Initiated by

Voluntary: Firm initiated

Reason for recall

Defective Container

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.

Code / lot info

Lot: EJA022, expiry: 04/30/2028

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →