Neogen Corporation FDA Record
Neogen Corporation has 2 FDA recalls, 18 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Neogen Corporation, the most recent on Sep 23, 2026.
- Latest recall
- D-0073-2025 · Class II · Oct 8, 2024
- Latest inspection
- Apr 7, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 18 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | 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 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 2 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Neogen Corporation FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 23, 2026 | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Center for Veterinary Medicine | |
| Jan 26, 2016 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0073-2025 | Class II | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed… | Oct 8, 2024 |
| D-0074-2025 | Class II | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug… | Oct 8, 2024 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 7, 2025 | Lansing, MI | Devices | No Action Indicated (NAI) | 1120041 |
| Dec 21, 2023 | Lexington, KY | Drugs | Voluntary Action Indicated (VAI) | 3009631819 |
| Oct 27, 2022 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3009631819 |
| Mar 16, 2021 | Lexington, KY | Veterinary | Voluntary Action Indicated (VAI) | 3009631819 |
| Jan 11, 2018 | Lexington, KY | Veterinary | Voluntary Action Indicated (VAI) | 3009631819 |
| Oct 7, 2016 | Lansing, MI | Devices | Voluntary Action Indicated (VAI) | 1120041 |
| Apr 28, 2016 | Lexington, KY | Veterinary | Voluntary Action Indicated (VAI) | 3009631819 |
| Apr 26, 2016 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3005038302 |
| Nov 17, 2014 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3009631819 |
| Apr 11, 2014 | Lansing, MI | Devices | No Action Indicated (NAI) | 1120041 |
| May 23, 2013 | Lexington, KY | Veterinary | Voluntary Action Indicated (VAI) | 3009631819 |
| Mar 13, 2013 | Lexington, KY | Devices | Voluntary Action Indicated (VAI) | 3005038302 |
| Dec 21, 2012 | Lexington, KY | Veterinary | Voluntary Action Indicated (VAI) | 3009631819 |
| Jan 9, 2012 | Lansing, MI | Devices | Voluntary Action Indicated (VAI) | 1120041 |
| Dec 21, 2011 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3009631819 |
| Mar 18, 2011 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3009631819 |
| Dec 23, 2009 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3009631819 |
| Dec 22, 2009 | Lexington, KY | Veterinary | No Action Indicated (NAI) | 3005038302 |
- 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.
Compliance Actions
FDA's compliance actions data lists 2 compliance actions under Neogen Corporation: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1120041 | Lansing, MI | 4 | Apr 7, 2025 |
| FEI 3009631819 | Lexington, KY | 11 | Dec 21, 2023 |
| FEI 3005038302 | Lexington, KY | 3 | Apr 26, 2016 |
Neogen Corporation and the FDA: common questions
Has Neogen Corporation received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Neogen Corporation. The most recent is dated Sep 23, 2026, with the subject "CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated".
Has Neogen Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Neogen Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Neogen Corporation?
The most recent FDA inspection on file ended Apr 7, 2025 at Lansing, MI and was classified NAI. FDA has 18 inspections of Neogen Corporation on file.
Has Neogen Corporation had an FDA recall?
Yes. Neogen Corporation has 2 FDA recalls on record. The most recent started Oct 8, 2024.
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