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Mylan Laboratories Limited

FDA Regulatory Profile

Mylan Laboratories Limited has 0 FDA recalls, 34 inspections, 0 510(k) clearances and 4 compliance actions on record.

Latest inspection
May 15, 2026 · OAI

Newer recall under related name Viatris: Oct 1, 2026, D-0049-2027.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections34Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions4Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Viatris
Same company group		260211Oct 1, 2026 (D-0049-2027)
Mylan Institutional
Same company group		24000Mar 7, 2025 (D-0291-2025)
Mylan
Same company group		5000Dec 20, 2016 (D-0444-2017)
Meda Pharmaceuticals
Same company group		10101Oct 17, 2011 (D-1418-2012)
Dpt Laboratories
Same company group		03240—
Viatris Pharmaceuticals
Same company group		00180—
Mylan Technologies
Same company group		0070—
Mylan Teoranta
Same company group		0070—

Recent FDA Inspections

DateSiteProductClassificationFEI
May 15, 2026Nashik, IndiaDrugsOfficial Action Indicated (OAI)3005587313
Nov 22, 2024Bengaluru, IndiaDrugsNo Action Indicated (NAI)3017932113
May 17, 2024Hosur, IndiaDrugsVoluntary Action Indicated (VAI)3008255419
Feb 24, 2023Bengaluru, IndiaDrugsNo Action Indicated (NAI)3007648351
May 27, 2022Anekal Taluk, Bangalore, IndiaDrugsVoluntary Action Indicated (VAI)3007512701
Sep 17, 2021Hosur, IndiaDrugsVoluntary Action Indicated (VAI)3008255419
Feb 28, 2020Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3007648351
Feb 7, 2020Nashik, IndiaDrugsNo Action Indicated (NAI)3005587313
May 24, 2019Pithampur, District Dhar, IndiaDrugsNo Action Indicated (NAI)3010453141
May 13, 2019Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3007648351
Jan 18, 2019Nashik, IndiaDrugsNo Action Indicated (NAI)3005587313
Nov 2, 2018Hyderabad, IndiaDrugsNo Action Indicated (NAI)3007720135
Apr 12, 2018Nashik, IndiaDrugsVoluntary Action Indicated (VAI)3005587313
Mar 2, 2018Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3007648351
Apr 18, 2017Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3007648351
Apr 4, 2017Anekal Taluk, Bangalore, IndiaDrugsVoluntary Action Indicated (VAI)3007512701
Feb 1, 2017Hyderabad, IndiaDrugsOfficial Action Indicated (OAI)3007720135
Sep 14, 2016Nashik, IndiaDrugsOfficial Action Indicated (OAI)3005587313
Apr 13, 2016Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3007648351
Feb 5, 2016Pithampur, District Dhar, IndiaDrugsVoluntary Action Indicated (VAI)3010453141

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 3005587313Nashik, India9May 15, 2026
FEI 3017932113Bengaluru, India1Nov 22, 2024
FEI 3008255419Hosur, India4May 17, 2024
FEI 3007648351Bengaluru, India8Feb 24, 2023
FEI 3007512701Anekal Taluk, Bangalore, India5May 27, 2022
FEI 3010453141Pithampur, District Dhar, India3May 24, 2019
FEI 3007720135Hyderabad, India2Nov 2, 2018
FEI 3008725991Valsad District, India2Jul 24, 2015

FDA data resources

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