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Cipla Limited

FDA Regulatory Profile

Cipla Limited has 14 FDA recalls, 46 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest recall
D-0197-2026 · Class II · Oct 31, 2025
Latest inspection
May 30, 2025 · VAI

Newer recall under related name Cipla Usa: Sep 18, 2026, D-0014-2027.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls14Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections46Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Cipla Usa
Same company group		24000Sep 18, 2026 (D-0014-2027)
Invagen Pharmaceuticals
Same company group		110210Nov 17, 2023 (D-0220-2024)

Recent Recalls

NumberClassProductDate
D-0197-2026Class IIPhytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by…Oct 31, 2025
D-1550-2022Class IIArformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2…Sep 29, 2022
D-1545-2022Class IIBudesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL…Sep 15, 2022
D-1498-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan…Aug 22, 2022
D-1499-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India…Aug 22, 2022
D-1328-2022Class IIDifluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles…Aug 2, 2022
D-1283-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S…Jul 14, 2022
D-0660-2021Class IISolifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna…Jun 10, 2021
D-0183-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx…Dec 17, 2020
D-0181-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx…Dec 17, 2020
D-0182-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx…Dec 17, 2020
D-0165-2021Class IIAzacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial…Dec 14, 2020
D-0382-2019Class IINevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd…Dec 14, 2018
D-1078-2015Class IIILevalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla…Apr 24, 2015

Recent FDA Inspections

DateSiteProductClassificationFEI
May 30, 2025Bangalore, IndiaDrugsVoluntary Action Indicated (VAI)3005857289
Nov 13, 2024Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3002806691
Jun 21, 2024Salcette, IndiaDrugsVoluntary Action Indicated (VAI)3004081307
May 8, 2024Kurkumbh Village, Dist. Pune, IndiaDrugsVoluntary Action Indicated (VAI)3002806702
Apr 4, 2024Raigad, IndiaDrugsVoluntary Action Indicated (VAI)3002806710
Feb 17, 2023Pithampur, District Dhar, IndiaDrugsOfficial Action Indicated (OAI)3008581988
Aug 26, 2022Salcette, IndiaDrugsOfficial Action Indicated (OAI)3004081307
Jan 31, 2020Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3002806691
Jan 24, 2020Bangalore, IndiaDrugsVoluntary Action Indicated (VAI)3005857289
Nov 13, 2019Raigad, IndiaDrugsVoluntary Action Indicated (VAI)3002806710
Sep 27, 2019Salcette, IndiaDrugsOfficial Action Indicated (OAI)3004081307
Jul 19, 2019Bengaluru, IndiaDrugsVoluntary Action Indicated (VAI)3002806691
May 17, 2019Pithampur, District Dhar, IndiaDrugsNo Action Indicated (NAI)3008581988
Mar 20, 2019Kurkumbh Village, Dist. Pune, IndiaDrugsVoluntary Action Indicated (VAI)3002806702
Jan 28, 2019Salcette, IndiaVeterinaryVoluntary Action Indicated (VAI)3004081307
Nov 30, 2018Kurkumbh Village, Dist. Pune, IndiaDrugsNo Action Indicated (NAI)3002806702
Sep 28, 2018Salcette, IndiaDrugsVoluntary Action Indicated (VAI)3004081307
Apr 13, 2018Pithampur, District Dhar, IndiaDrugsVoluntary Action Indicated (VAI)3008581988
Dec 6, 2017Raigad, IndiaDrugsVoluntary Action Indicated (VAI)3002806710
Jun 16, 2017Salcette, IndiaDrugsVoluntary Action Indicated (VAI)3004081307

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 3005857289Bangalore, India4May 30, 2025
FEI 3002806691Bengaluru, India7Nov 13, 2024
FEI 3004081307Salcette, India12Jun 21, 2024
FEI 3002806702Kurkumbh Village, Dist. Pune, India7May 8, 2024
FEI 3002806710Raigad, India7Apr 4, 2024
FEI 3008581988Pithampur, District Dhar, India6Feb 17, 2023
FEI 3007021905Mumbai, India3Mar 18, 2016

FDA data resources

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