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Lupin Limited

FDA Regulatory Profile

Lupin Limited has 4 FDA recalls, 47 inspections, 0 510(k) clearances and 5 compliance actions on record.

Latest recall
D-0092-2018 · Class II · Nov 17, 2017
Latest inspection
Nov 21, 2025 · VAI

Newer recall under related name Lupin Pharmaceuticals: Aug 3, 2026, D-0789-2026.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls4Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections47Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions5Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Lupin Pharmaceuticals
Same company group		123040Aug 3, 2026 (D-0789-2026)
Lupin Research
Same company group		0010—

Recent Recalls

NumberClassProductDate
D-0092-2018Class IIPravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin…Nov 17, 2017
D-1516-201Class IIIEscitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals…Mar 24, 2016
D-1493-2016Class IIIAmlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin…Feb 19, 2016
D-1492-2016Class IIIAmlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin…Feb 19, 2016

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 21, 2025Verna, IndiaDrugsVoluntary Action Indicated (VAI)3004819820
Sep 16, 2025Nagpur, IndiaDrugsVoluntary Action Indicated (VAI)3015392060
Jul 17, 2025Pithampur, IndiaDrugsOfficial Action Indicated (OAI)3007549629
Jul 17, 2025Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3009107538
Sep 27, 2024Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3009831799
Jun 13, 2024Nagpur, IndiaDevicesNo Action Indicated (NAI)3015392060
Mar 15, 2024Aurangabad, IndiaDrugsVoluntary Action Indicated (VAI)3004995645
Jul 11, 2023Nagpur, IndiaDrugsVoluntary Action Indicated (VAI)3009843207
Mar 24, 2023Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3012681202
Nov 23, 2022Mandideep, IndiaDrugsOfficial Action Indicated (OAI)3002807511
Apr 4, 2022Tarapur, Thane, IndiaDrugsOfficial Action Indicated (OAI)3002807512
Sep 18, 2021Verna, IndiaDrugsVoluntary Action Indicated (VAI)3004819820
Feb 14, 2020Aurangabad, IndiaDrugsNo Action Indicated (NAI)3004995645
Feb 11, 2020Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3009831799
Sep 20, 2019Tarapur, Thane, IndiaDrugsOfficial Action Indicated (OAI)3002807512
Aug 8, 2019Nagpur, IndiaDrugsNo Action Indicated (NAI)3009843207
Feb 8, 2019Verna, IndiaDrugsOfficial Action Indicated (OAI)3004819820
Jan 25, 2019Pithampur, IndiaDrugsOfficial Action Indicated (OAI)3007549629
Jan 18, 2019Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3012681202
Dec 4, 2018Mandideep, IndiaDrugsOfficial Action Indicated (OAI)3002807511

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 3004819820Verna, India9Nov 21, 2025
FEI 3015392060Nagpur, India2Sep 16, 2025
FEI 3007549629Pithampur, India6Jul 17, 2025
FEI 3009107538Pithampur, India3Jul 17, 2025
FEI 3009831799Pithampur, India4Sep 27, 2024
FEI 3004995645Aurangabad, India5Mar 15, 2024
FEI 3009843207Nagpur, India4Jul 11, 2023
FEI 3012681202Navi Mumbai, India2Mar 24, 2023
FEI 3002807511Mandideep, India6Nov 23, 2022
FEI 3002807512Tarapur, Thane, India5Apr 4, 2022
FEI 3004529241Mumbai, India1Jun 19, 2015

FDA data resources

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