October 2025 FDA Recall Tylenol Extra Strength by Kenvue Brands Llc
D-0121-2026 - Defective Container
This Class II drug recall was voluntarily initiated by Kenvue Brands Llc on October 21, 2025 for the product Tylenol Extra Strength. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0121-2026
Defective Container
10-21-2025
11-05-2025
3,816 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kenvue Brands LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide - CO, IL, OH and IN.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: EJA022, expiry: 04/30/2028
