Midlab Incorporated

FDA Regulatory Profile

Midlab Incorporated has 8 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0087-2025 · Class II · Nov 6, 2024
Latest inspection
Sep 13, 2024 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls8Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0087-2025Class IIMAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For…Nov 6, 2024
D-0091-2025Class IIGenuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the…Nov 6, 2024
D-0090-2025Class IIROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78…Nov 6, 2024
D-0092-2025Class IICompliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces…Nov 6, 2024
D-0088-2025Class IIboardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for…Nov 6, 2024
D-0089-2025Class IIArray Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR…Nov 6, 2024
D-1464-2022Class IICorsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1…Aug 8, 2022
D-1463-2022Class IIMaxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78…Aug 8, 2022

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 13, 2024Athens, TNDrugsOfficial Action Indicated (OAI)3001236208
Aug 5, 2022Athens, TNDrugsOfficial Action Indicated (OAI)3001236208
May 24, 2017Athens, TNDrugsNo Action Indicated (NAI)3001236208
Feb 14, 2012Athens, TNDrugsNo Action Indicated (NAI)3001236208

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

FacilityLocationInspectionsLatest
FEI 3001236208Athens, TN4Sep 13, 2024

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.