Medications & Supplements/Over-the-Counter

Tylenol Extra Strength Caplets Recalled for Defective Container

Agency Publication Date: October 28, 2025

Summary

Kenvue Brands LLC has recalled 3,816 bottles of Tylenol Extra Strength Acetaminophen (500mg) caplets because of a defective container. This recall affects the 24-count bottles of Tylenol distributed by Johnson & Johnson Consumer Inc. and McNeil Consumer Healthcare. Consumers should check their medicine for lot number EJA022 with an expiration date of April 30, 2028.

Risk

A defective container may compromise the integrity of the product or prevent the packaging from performing as intended to protect the medication. No specific injuries or incidents have been reported in the current data.

What You Should Do

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
Identify if your product is affected by checking the label for the product name 'Tylenol Extra Strength' 500mg caplets in 24-count bottles, specifically lot number EJA022 with an expiration date of 04/30/2028 (NDC 50580-378-04).
Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: TYLENOL, Acetaminophen, Extra Strength (24 Caplets)by Tylenol

Variants: 500mg, Caplets

Lot Numbers:

EJA022 (Exp 04/30/2028)

NDC:

50580-378-04

Recall #: D-0121-2026; Quantity: 3,816 bottles; Distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97850

Status: Active

Manufacturer: Kenvue Brands LLC

Sold By: Retail drug stores

Manufactured In: United States

Units Affected: 3,816 bottles

Distributed To: Colorado, Illinois, Ohio, Indiana

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.

Identify if your product is affected by checking the label for the product name 'Tylenol Extra Strength' 500mg caplets in 24-count bottles, specifically lot number EJA022 with an expiration date of 04/30/2028 (NDC 50580-378-04).

Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.