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Zydus Lifesciences Limited

FDA Regulatory Profile

Zydus Lifesciences Limited has 0 FDA recalls, 59 inspections, 0 510(k) clearances and 5 compliance actions on record.

Latest inspection
May 5, 2026 · VAI

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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
Inspections59Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions5Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 5, 2026Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3012977526
Jun 17, 2025Matoda, IndiaDrugsVoluntary Action Indicated (VAI)3007621329
Apr 25, 2025Dabhasa, Vadodara, IndiaDrugsVoluntary Action Indicated (VAI)3002806475
Mar 14, 2025Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3003696998
Feb 14, 2025Kalyan, IndiaDrugsNo Action Indicated (NAI)3006809732
Feb 14, 2025Ahmedabad, IndiaDrugsNo Action Indicated (NAI)3006026405
Jul 19, 2024Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3008957483
Apr 23, 2024Jarod, IndiaDrugsOfficial Action Indicated (OAI)3013712903
Mar 27, 2024Matoda, IndiaDrugsOfficial Action Indicated (OAI)3007621329
Jun 13, 2023Ahmedabad, IndiaDrugsNo Action Indicated (NAI)3012977526
Mar 24, 2023Matoda, IndiaDrugsVoluntary Action Indicated (VAI)3007938603
Aug 5, 2022Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3002984011
Mar 10, 2022Jarod, IndiaDrugsVoluntary Action Indicated (VAI)3013712903
Mar 9, 2020Solan, IndiaDrugsNo Action Indicated (NAI)3005430968
Mar 4, 2020Moraiya, IndiaDrugsNo Action Indicated (NAI)3007834858
Feb 4, 2020Matoda, IndiaDrugsNo Action Indicated (NAI)3007621329
Dec 20, 2019Ahmedabad, IndiaDrugsNo Action Indicated (NAI)3006026405
Oct 11, 2019Dabhasa, Vadodara, IndiaDrugsNo Action Indicated (NAI)3002806475
Jul 26, 2019Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3003696998
Jul 19, 2019Solan, IndiaDrugsNo Action Indicated (NAI)3005430968

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 3012977526Ahmedabad, India2May 5, 2026
FEI 3007621329Matoda, India9Jun 17, 2025
FEI 3002806475Dabhasa, Vadodara, India6Apr 25, 2025
FEI 3003696998Ankleshwar, India4Mar 14, 2025
FEI 3006026405Ahmedabad, India4Feb 14, 2025
FEI 3006809732Kalyan, India4Feb 14, 2025
FEI 3008957483Ahmedabad, India3Jul 19, 2024
FEI 3013712903Jarod, India2Apr 23, 2024
FEI 3007938603Matoda, India5Mar 24, 2023
FEI 3002984011Ahmedabad, India10Aug 5, 2022
FEI 3005430968Solan, India6Mar 9, 2020
FEI 3007834858Moraiya, India3Mar 4, 2020
FEI 3006595385Ahmedabad, India1Dec 6, 2014

FDA data resources

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