Why it was recalled
Defective Container
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 numbers, UPCs & expiration codes
Lot: EJA022, expiry: 04/30/2028
Where it was sold
U.S. Nationwide - CO, IL, OH and IN.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0121-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 21, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 3,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kenvue Brands LLC
Original FDA data
Every field from FDA enforcement report D-0121-2026, exactly as published.
Show all FDA fields
- City
- Summitt
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97850
- Address
- 1 Kenvue Way
- Code information
- Lot: EJA022, expiry: 04/30/2028
- Postal code
- 07901
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0121-2026
- Classification
- Class II
- Recalling firm
- Kenvue Brands LLC
- Product quantity
- 3,816 bottles
- Reason for recall
- Defective Container
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide - CO, IL, OH and IN.
- Recall initiation date
- Oct 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2025