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CLASS II · ModerateFDA

Kenvue Brands LLC recalls TYLENOL

📅 Oct 21, 2025 · 📍 Nationwide
Recalling company
Kenvue Brands LLC
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.
Reason
Defective Container
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 21, 2025
Reported
Nov 5, 2025
Distribution
U.S. Nationwide - CO, IL, OH and IN.
Status
Ongoing
Quantity
3,816 bottles
Lot / codes
Lot: EJA022, expiry: 04/30/2028
Company location
Summitt, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0121-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0121-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.