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KENIL HEALTHCARE PRIVATE LIMITED

FDA Regulatory Profile

KENIL HEALTHCARE PRIVATE LIMITED has 20 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0428-2025 · Class II · Apr 24, 2025
Latest inspection
Dec 11, 2024 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls20Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0428-2025Class IIRapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by…Apr 24, 2025
D-0423-2025Class IICURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by…Apr 24, 2025
D-0434-2025Class IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ…Apr 24, 2025
D-0439-2025Class IINature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43…Apr 24, 2025
D-0427-2025Class IIOptim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1…Apr 24, 2025
D-0433-2025Class IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15…Apr 24, 2025
D-0438-2025Class IINature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24…Apr 24, 2025
D-0425-2025Class IIKOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4…Apr 24, 2025
D-0435-2025Class IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130…Apr 24, 2025
D-0436-2025Class IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g)…Apr 24, 2025
D-0437-2025Class IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181…Apr 24, 2025
D-0432-2025Class IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85…Apr 24, 2025
D-0422-2025Class IICURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por…Apr 24, 2025
D-0426-2025Class IIKOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5%…Apr 24, 2025
D-0431-2025Class IIMaximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ…Apr 24, 2025
D-0424-2025Class IIKingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New…Apr 24, 2025
D-0440-2025Class IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g)…Apr 24, 2025
D-0430-2025Class IICinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ…Apr 24, 2025
D-0429-2025Class IIRapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B…Apr 24, 2025
D-0421-2025Class IIArtridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint…Apr 24, 2025

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 11, 2024Mehsana, IndiaDrugsOfficial Action Indicated (OAI)3022380309

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 3022380309Mehsana, India1Dec 11, 2024

FDA data resources

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