Tylenol Extra Strength Tablet, Film Coated
FDA Recall NDC 50580-378
Latest: Class II · Status: Ongoing · Initiated Oct 21, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tylenol Extra Strength (NDC 50580-378). A significant event, classified as Class II, was initiated on Oct 21, 2025 by Kenvue Brands Llc. The reported reason for this action was: "Defective Container"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective Container
Oct 21, 2025
Nov 05, 2025
3,816 bottles
Recall Profile & Regulatory Data
Event ID
97850
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Kenvue Brands LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide - CO, IL, OH and IN.
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.
Batch or Lot Expiration Information
Lot# Lot: EJA022, expiry: 04/30/2028
Affected Packages Involved in this Recall
50580-378-01Tylenol Extra Strength
50580-378-02Tylenol Extra Strength
50580-378-03Tylenol Extra Strength
50580-378-04Tylenol Extra Strength
50580-378-05Tylenol Extra Strength
50580-378-06Tylenol Extra Strength
50580-378-07Tylenol Extra Strength
50580-378-08Tylenol Extra Strength
50580-378-37Tylenol Extra Strength
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
