FDA Recall D-0121-2026
Kenvue Brands LLC · Summitt, NJ
Class II Ongoing 205 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Defective Container
Recall record
- Recall number
D-0121-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide - CO, IL, OH and IN.
- Recall initiated
- 2025-10-21
- Classified by FDA Center
- 2025-10-28
- FDA published
- 2025-11-05
- Recalling firm
- Kenvue Brands LLC
- Firm location
- Summitt, NJ
Drug identification
- Brand name(s)
- TYLENOL EXTRA STRENGTH
- Generic name(s)
- ACETAMINOPHEN
- Manufacturer(s)
- Kenvue Brands LLC
- NDC(s)
50580-378- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.