Colgate-Palmolive Co.
FDA Regulatory Profile
Colgate-Palmolive Co. has 7 FDA recalls, 25 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-1084-2023 · Class II · Aug 10, 2023
- Latest inspection
- Aug 20, 2025 · NAI
- Latest 510(k)
- Jun 5, 2014
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 7 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 25 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1084-2023 | Class II | hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT… | Aug 10, 2023 |
| D-0521-2017 | Class III | PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free… | Feb 13, 2017 |
| Z-1873-2012 | Class II | Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by… | Mar 23, 2012 |
| Z-1871-2012 | Class II | Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive… | Mar 23, 2012 |
| Z-1872-2012 | Class II | Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by… | Mar 23, 2012 |
| Z-1870-2012 | Class II | Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New… | Mar 23, 2012 |
| Z-1874-2012 | Class II | Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist… | Mar 23, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 20, 2025 | Piscataway, NJ | Drugs | No Action Indicated (NAI) | 2221095 |
| Mar 6, 2025 | Hodges, SC | Drugs | No Action Indicated (NAI) | 3011856815 |
| Feb 16, 2024 | Piscataway, NJ | Drugs | No Action Indicated (NAI) | 2221095 |
| Feb 14, 2024 | Bowling Green, KY | Veterinary | No Action Indicated (NAI) | 3001195096 |
| Jan 26, 2024 | Piscataway, NJ | Devices | No Action Indicated (NAI) | 2221095 |
| Jan 11, 2024 | Morristown, TN | Drugs | No Action Indicated (NAI) | 3005874880 |
| Jul 26, 2023 | Bowling Green, KY | Veterinary | No Action Indicated (NAI) | 3001195096 |
| Mar 31, 2022 | Morristown, TN | Drugs | No Action Indicated (NAI) | 3005874880 |
| Jul 15, 2021 | Morristown, TN | Devices | Voluntary Action Indicated (VAI) | 3005874880 |
| May 30, 2019 | Piscataway, NJ | Drugs | Voluntary Action Indicated (VAI) | 2221095 |
| Feb 2, 2018 | Bowling Green, KY | Veterinary | No Action Indicated (NAI) | 3001195096 |
| Oct 31, 2017 | Piscataway, NJ | Drugs | No Action Indicated (NAI) | 2221095 |
| Dec 8, 2016 | Hodges, SC | Drugs | No Action Indicated (NAI) | 3011856815 |
| Apr 20, 2016 | Morristown, TN | Drugs | No Action Indicated (NAI) | 3005874880 |
| Mar 17, 2016 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2211157 |
| Sep 9, 2013 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2211157 |
| Jul 3, 2013 | Bowling Green, KY | Veterinary | Voluntary Action Indicated (VAI) | 3001195096 |
| May 22, 2013 | Piscataway, NJ | Drugs | No Action Indicated (NAI) | 2221095 |
| Nov 9, 2011 | Bowling Green, KY | Veterinary | No Action Indicated (NAI) | 3001195096 |
| Apr 7, 2011 | Morristown, NJ | Drugs | Voluntary Action Indicated (VAI) | 2211157 |
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 2221095 | Piscataway, NJ | 7 | Aug 20, 2025 |
| FEI 3011856815 | Hodges, SC | 2 | Mar 6, 2025 |
| FEI 3001195096 | Bowling Green, KY | 6 | Feb 14, 2024 |
| FEI 3005874880 | Morristown, TN | 5 | Jan 11, 2024 |
| FEI 2211157 | Morristown, NJ | 3 | Mar 17, 2016 |
| FEI 1000305988 | Cambridge, OH | 2 | Apr 5, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH | Jun 5, 2014 |
| K103461 | COLGATE DESENSITIZING DENTAL CREAM | Sep 13, 2011 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Apr 27, 1995 |
| K901955 | PERIOGARD(R) PERIOPEN | Apr 15, 1991 |
| K883335 | COLGATE DENTAL FLOSS | Aug 26, 1988 |