TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil
Summary
The FDA issued a Class II for TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: by Kenvue Brands LLC. Reason: Defective Container.
Details
Source
Drug Recall
External ID
D-0121-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: EJA022, expiry: 04/30/2028
Quantity Affected: 3,816 bottles
Reason for Recall
Defective Container
Distribution
U.S. Nationwide - CO, IL, OH and IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-21
Company
Summitt, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kenvue Brands LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kenvue Brands LLC have FDA actions?
This is the only FDA action we have on record for Kenvue Brands LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0121-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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