Dabur India Limited

FDA Regulatory Profile

Dabur India Limited has 14 FDA recalls, 8 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0640-2026 · Class II · Jun 2, 2026
Latest inspection
Jan 16, 2026 · OAI

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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
Inspections8Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0640-2026Class IIMed Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC…Jun 2, 2026
D-0641-2026Class IIMed Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5…Jun 2, 2026
D-0638-2026Class IIMed Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC…Jun 2, 2026
D-0633-2026Class IIRapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg…Jun 2, 2026
D-0631-2026Class IICircle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg)…Jun 2, 2026
D-0642-2026Class IIMed Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B…Jun 2, 2026
D-0639-2026Class IIMed Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59…Jun 2, 2026
D-0634-2026Class IICura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New…Jun 2, 2026
D-0635-2026Class IIMed Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box…Jun 2, 2026
D-0636-2026Class IIMed Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line…Jun 2, 2026
D-0630-2026Class IILucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate…Jun 2, 2026
D-0632-2026Class IILil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg)…Jun 2, 2026
D-0629-2026Class IILucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g)…Jun 2, 2026
D-0637-2026Class IIMed Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for…Jun 2, 2026

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 16, 2026Dadra And Nagar Haveli, IndiaDrugsOfficial Action Indicated (OAI)3001413302
Jul 20, 2022Solan, IndiaFood/CosmeticsNo Action Indicated (NAI)3009907990
Dec 6, 2019Dadra And Nagar Haveli, IndiaDrugsVoluntary Action Indicated (VAI)3001413302
Jul 6, 2017Baddi, IndiaFood/CosmeticsNo Action Indicated (NAI)3007140482
Oct 14, 2016Dadra And Nagar Haveli, IndiaDrugsVoluntary Action Indicated (VAI)3001413302
Jul 22, 2016Tonk, IndiaFood/CosmeticsVoluntary Action Indicated (VAI)3008450520
Jul 11, 2016Baddi, IndiaFood/CosmeticsVoluntary Action Indicated (VAI)3007140482
Jul 25, 2014Alwar, IndiaFood/CosmeticsOfficial Action Indicated (OAI)3004326814

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 3001413302Dadra And Nagar Haveli, India3Jan 16, 2026
FEI 3009907990Solan, India1Jul 20, 2022
FEI 3007140482Baddi, India2Jul 6, 2017
FEI 3008450520Tonk, India1Jul 22, 2016
FEI 3004326814Alwar, India1Jul 25, 2014

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