Recalls / Class II
Class IID-0121-2026
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.
- Brand name
- Tylenol Extra Strength
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 50580-378
- FDA application
- M013
- Affected lot / code info
- Lot: EJA022, expiry: 04/30/2028
Why it was recalled
Defective Container
Recalling firm
- Firm
- Kenvue Brands LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Kenvue Way, N/A, Summitt, New Jersey 07901
Distribution
- Quantity
- 3,816 bottles
- Distribution pattern
- U.S. Nationwide - CO, IL, OH and IN.
Timeline
- Recall initiated
- 2025-10-21
- FDA classified
- 2025-10-28
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0121-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.