Kenvue Brands LLC
FDA Regulatory Profile
Kenvue Brands LLC has 1 FDA recall, 29 inspections, 0 510(k) clearances and 3 compliance actions on record.
- Latest recall
- D-0121-2026 · Class II · Oct 21, 2025
- Latest inspection
- Apr 8, 2026 · NAI
Reviewing Kenvue Brands LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Kenvue Brands LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 29 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0121-2026 | Class II | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson… | Oct 21, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 8, 2026 | Mooresville, IN | Food/Cosmetics | No Action Indicated (NAI) | 3008868758 |
| Apr 2, 2026 | Lititz, PA | Drugs | No Action Indicated (NAI) | 2510770 |
| Feb 10, 2026 | Fort Washington, PA | Drugs | Voluntary Action Indicated (VAI) | 2510184 |
| Aug 25, 2023 | Summit, NJ | Food/Cosmetics | No Action Indicated (NAI) | 2214133 |
| Aug 2, 2023 | Summit, NJ | Food/Cosmetics | No Action Indicated (NAI) | 2214133 |
| Jan 27, 2023 | Lititz, PA | Drugs | No Action Indicated (NAI) | 2510770 |
| Oct 7, 2022 | Fort Washington, PA | Drugs | No Action Indicated (NAI) | 2510184 |
| May 3, 2021 | Fort Washington, PA | Drugs | No Action Indicated (NAI) | 2510184 |
| Dec 11, 2017 | Summit, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2214133 |
| Jul 7, 2017 | Lititz, PA | Drugs | Voluntary Action Indicated (VAI) | 2510770 |
| Dec 9, 2016 | Fort Washington, PA | Drugs | No Action Indicated (NAI) | 2510184 |
| Sep 21, 2015 | Lititz, PA | Drugs | Voluntary Action Indicated (VAI) | 2510770 |
| Aug 14, 2015 | Fort Washington, PA | Drugs | No Action Indicated (NAI) | 2510184 |
| Jul 9, 2015 | Summit, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2214133 |
| Jun 17, 2015 | Summit, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2214133 |
| May 6, 2015 | Fort Washington, PA | Drugs | Voluntary Action Indicated (VAI) | 2510184 |
| Mar 10, 2014 | Summit, NJ | Devices | Voluntary Action Indicated (VAI) | 2214133 |
| Apr 10, 2013 | Summit, NJ | Devices | Official Action Indicated (OAI) | 2214133 |
| Mar 27, 2013 | Summit, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2214133 |
| Jan 19, 2012 | Summit, NJ | Devices | Official Action Indicated (OAI) | 2214133 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.