FDA recall D-0121-2026

Kenvue Brands LLC · Class II · drug

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.

Reason for recall

Defective Container

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-10-21
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Summitt, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0121-2026