Neogen Corporation FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "Neogen Corporation".

Latest recall
D-0073-2025 · Class II · Oct 8, 2024
Latest inspection
Apr 7, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections18Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Neogen Corporation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Neogen Corporation: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600100
202510000
202400020
202310000
202210000
202110000
202000000
201900000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Neogen Corporation FDA Warning Letters

2 warning letters from Jan 26, 2016 to Sep 23, 2026.

IssuedSubjectIssuing officeClose-out letter
Sep 23, 2026CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedCenter for Veterinary Medicine
Jan 26, 2016

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

2 recall records on Oct 8, 2024.

NumberClassProductDate
D-0073-2025Class IILICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed…Oct 8, 2024
D-0074-2025Class IILICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug…Oct 8, 2024

Recent FDA inspections

18 inspections from Dec 22, 2009 to Apr 7, 2025.

DateSiteProductClassificationFEI
Apr 7, 2025Lansing, MIDevicesNo Action Indicated (NAI)1120041
Dec 21, 2023Lexington, KYDrugsVoluntary Action Indicated (VAI)3009631819
Oct 27, 2022Lexington, KYVeterinaryNo Action Indicated (NAI)3009631819
Mar 16, 2021Lexington, KYVeterinaryVoluntary Action Indicated (VAI)3009631819
Jan 11, 2018Lexington, KYVeterinaryVoluntary Action Indicated (VAI)3009631819
Oct 7, 2016Lansing, MIDevicesVoluntary Action Indicated (VAI)1120041
Apr 28, 2016Lexington, KYVeterinaryVoluntary Action Indicated (VAI)3009631819
Apr 26, 2016Lexington, KYVeterinaryNo Action Indicated (NAI)3005038302
Nov 17, 2014Lexington, KYVeterinaryNo Action Indicated (NAI)3009631819
Apr 11, 2014Lansing, MIDevicesNo Action Indicated (NAI)1120041
May 23, 2013Lexington, KYVeterinaryVoluntary Action Indicated (VAI)3009631819
Mar 13, 2013Lexington, KYDevicesVoluntary Action Indicated (VAI)3005038302
Dec 21, 2012Lexington, KYVeterinaryVoluntary Action Indicated (VAI)3009631819
Jan 9, 2012Lansing, MIDevicesVoluntary Action Indicated (VAI)1120041
Dec 21, 2011Lexington, KYVeterinaryNo Action Indicated (NAI)3009631819
Mar 18, 2011Lexington, KYVeterinaryNo Action Indicated (NAI)3009631819
Dec 23, 2009Lexington, KYVeterinaryNo Action Indicated (NAI)3009631819
Dec 22, 2009Lexington, KYVeterinaryNo 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

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.

Most recent: Warning Letter, Sep 24, 2026.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1120041Lansing, MI4Apr 7, 2025
FEI 3009631819Lexington, KY11Dec 21, 2023
FEI 3005038302Lexington, KY3Apr 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.