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Drug FDA Class II Ongoing Quality

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.

Kenvue Brands LLC Published Nov 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Kenvue Brands LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective Container

Affected products (1)

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.

TYLENOL EXTRA STRENGTH · 3,816 bottles

NDC: 50580-378, 50580-378-01, 50580-378-02, 50580-378-03, 50580-378-04, 50580-378-05, 50580-378-06, 50580-378-07, 50580-378-08, 50580-378-37
Lot codes: EJA022
Code info: Lot: EJA022, expiry: 04/30/2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 21, 2025
  2. Published
    Nov 5, 2025
Recall number
D-0121-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.