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Micro Labs Limited

FDA Regulatory Profile

Micro Labs Limited has 2 FDA recalls, 26 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0348-2024 · Class II · Feb 12, 2024
Latest inspection
Jun 30, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections26Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0348-2024Class IIClobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722…Feb 12, 2024
D-0388-2024Class IITelmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited…Feb 9, 2024

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 30, 2026Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3009310198
May 15, 2026Bengaluru, IndiaDrugsNo Action Indicated (NAI)3011602583
Aug 29, 2025Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3004939494
Jul 25, 2025Bengaluru, IndiaDrugsNo Action Indicated (NAI)3011602583
May 30, 2025Verna, IndiaDrugsVoluntary Action Indicated (VAI)3005210225
Feb 7, 2025Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3004495158
Apr 3, 2024Bengaluru, IndiaDrugsNo Action Indicated (NAI)3017157902
Dec 8, 2023Bengaluru, IndiaDrugsOfficial Action Indicated (OAI)3004939494
May 12, 2023Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3009310198
May 6, 2022Anekal, Bengaluru, IndiaDrugsNo Action Indicated (NAI)3014804711
Jan 24, 2020Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3004495158
Feb 16, 2019Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3004939494
Feb 15, 2019Verna, IndiaDrugsVoluntary Action Indicated (VAI)3005210225
Nov 16, 2018Bengaluru, IndiaDrugsNo Action Indicated (NAI)3011602583
Jul 13, 2018Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3011602583
Mar 22, 2018Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3009310198
Mar 16, 2018Bengaluru, IndiaDrugsNo Action Indicated (NAI)3004495158
Apr 14, 2017Verna, IndiaDrugsNo Action Indicated (NAI)3005210225
Mar 2, 2017Bengaluru, IndiaDrugsNo Action Indicated (NAI)3004939494
Dec 18, 2015Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3004495158

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 3009310198Bengaluru, India5Jun 30, 2026
FEI 3011602583Bengaluru, India4May 15, 2026
FEI 3004939494Bengaluru, India5Aug 29, 2025
FEI 3005210225Verna, India6May 30, 2025
FEI 3004495158Bengaluru, India4Feb 7, 2025
FEI 3017157902Bengaluru, India1Apr 3, 2024
FEI 3014804711Anekal, Bengaluru, India1May 6, 2022

FDA data resources

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