Home / Recalls / Kenvue Brands LLC / D-0121-2026

D-0121-2026 Class II Ongoing

Recalled by Kenvue Brands LLC — Summitt, NJ

FDA drug recall D-0121-2026 was initiated by Kenvue Brands LLC on Oct 21, 2025 and is designated Class II. Reason for recall: Defective Container The recall status is ongoing. Affected quantity: 3,816 bottles.

Recall Details

Product Type: Drugs
Report Date: Nov 5, 2025
Initiation Date: Oct 21, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,816 bottles

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

Distribution Pattern

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

Code Information

Lot: EJA022, expiry: 04/30/2028

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0121-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.