Estee Lauder Inc FDA Record
Estee Lauder Inc has 3 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Estee Lauder Inc" is on file.
- Latest recall
- D-1132-2019 · Class III · Mar 15, 2019
- Latest inspection
- Mar 14, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 1 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1132-2019 | Class III | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding… | Mar 15, 2019 |
| D-1452-2014 | Class III | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6… | Jun 6, 2014 |
| D-151-2013 | Class III | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad… | Oct 23, 2012 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Melville, NY | Drugs | No Action Indicated (NAI) | 2418643 |
| Jan 26, 2018 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| Aug 6, 2015 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| Aug 5, 2013 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| May 25, 2012 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| May 25, 2011 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| Feb 23, 2010 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
| Apr 27, 2009 | Melville, NY | Drugs | Voluntary Action Indicated (VAI) | 2418643 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2418643 | Melville, NY | 8 | Mar 14, 2025 |
Estee Lauder Inc and the FDA: common questions
Has Estee Lauder Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Estee Lauder Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Estee Lauder Inc received an FDA Form 483?
FDA has not published a Form 483 for "Estee Lauder Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Estee Lauder Inc?
The most recent FDA inspection on file ended Mar 14, 2025 at Melville, NY and was classified NAI. FDA has 8 inspections of Estee Lauder Inc on file.
Has Estee Lauder Inc had an FDA recall?
Yes. Estee Lauder Inc has 3 FDA recalls on record. The most recent started Mar 15, 2019.
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