Viatris Pharmaceuticals LLC

FDA Regulatory Profile

Viatris Pharmaceuticals LLC has 0 FDA recalls, 18 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 18, 2026 · VAI

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
Inspections18Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 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)
Mylan Laboratories Limited
Same company group
00334—
Dpt Laboratories
Same company group
03240—
Mylan Technologies
Same company group
0070—
Mylan Teoranta
Same company group
0070—
Mylan Laboratories
Same company group
0010—

Recent FDA Inspections

DateSiteProductClassificationFEI
May 18, 2026Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Jun 13, 2025Barceloneta, PRDrugsNo Action Indicated (NAI)2627208
Feb 17, 2022Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Dec 20, 2019Barceloneta, PRDrugsVoluntary Action Indicated (VAI)2627208
Mar 28, 2018Barceloneta, PRDrugsVoluntary Action Indicated (VAI)2627208
Jan 26, 2018Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Dec 8, 2016Barceloneta, PRDrugsNo Action Indicated (NAI)2627208
Jul 26, 2016Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Jul 2, 2015Barceloneta, PRDrugsVoluntary Action Indicated (VAI)2627208
Jun 19, 2015Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Mar 11, 2014Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Aug 20, 2013Barceloneta, PRDrugsVoluntary Action Indicated (VAI)2627208
Jul 16, 2013Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Aug 10, 2012Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Sep 23, 2011Barceloneta, PRDrugsOfficial Action Indicated (OAI)2627208
Jan 26, 2011Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619
Feb 8, 2010Barceloneta, PRDrugsVoluntary Action Indicated (VAI)2627208
Mar 25, 2009Vega Baja, PRDrugsVoluntary Action Indicated (VAI)2623619

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 2623619Vega Baja, PR10May 18, 2026
FEI 2627208Barceloneta, PR8Jun 13, 2025

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