FDA Drug recall D-0121-2026
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare… by Kenvue Brands, citing defective Container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0121-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-21 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kenvue Brands |
| Distribution | US |
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
Identifiers
| ndc | 50580-378-01 |
|---|---|
| ndc | 50580-378-02 |
| ndc | 50580-378-03 |
| ndc | 50580-378-04 |
| ndc | 50580-378-05 |
| ndc | 50580-378-06 |
| ndc | 50580-378-07 |
| ndc | 50580-378-08 |
| ndc | 50580-378-37 |
| code_info | Lot: EJA022, expiry: 04/30/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0121-2026%22
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