TYLENOL — Class II drug recall D-0121-2026
Ongoing recall by Kenvue Brands LLC, reported 2025-11-05, distributed nationwide. Defective Container
| Recall number | D-0121-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kenvue Brands LLC, Summitt, NJ, United States |
| Recall initiated | 2025-10-21 |
| Classified | 2025-10-28 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,816 bottles |
| Reason classes | packaging |
| NDC | 50580-0378, 50580-0378-01, 50580-0378-02, 50580-0378-03, 50580-0378-04, 50580-0378-05, 50580-0378-06, 50580-0378-07, 50580-0378-08, 50580-0378-37 |
| Lot numbers | EJA022 |
| Expiration dates | 2028-04-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0121-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.