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Lupin Pharmaceuticals Inc.

FDA Regulatory Profile

Lupin Pharmaceuticals Inc. has 123 FDA recalls (5 Class I), 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0789-2026 · Class II · Aug 3, 2026
Latest inspection
May 23, 2014 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls123 (5 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Lupin Limited
Same company group		40425Nov 17, 2017 (D-0092-2018)
Lupin
Same company group		0050—
Lupin Research
Same company group		0010—

Recent Recalls

NumberClassProductDate
D-0789-2026Class IIClobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals…Aug 3, 2026
D-0723-2026Class IIGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for…Jun 23, 2026
D-0655-2026Class IIprednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02)…Jun 4, 2026
D-0541-2026Class IILiraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…Apr 24, 2026
D-0220-2026Class IIGanirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2'…Nov 13, 2025
D-0227-2026Class IISertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin…Nov 5, 2025
D-0542-2025Class IIAmlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured…Jul 2, 2025
D-0537-2025Class IIclomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite…Jun 27, 2025
D-0532-2025Class IILisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for…Jun 20, 2025
D-0377-2025Class IIclomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin…Apr 10, 2025
D-0167-2025Class IILevothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for…Dec 20, 2024
D-0052-2025Class IIRamipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c)…Oct 23, 2024
D-0053-2025Class IIRamipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c)…Oct 23, 2024
D-0054-2025Class IIRamipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c)…Oct 23, 2024
D-0648-2024Class IICefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin…Aug 21, 2024
D-0559-2024Class IICefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only…May 30, 2024
D-0518-2024Class IICefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured…May 8, 2024
D-0496-2024Class IICefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only…Apr 24, 2024
D-0497-2024Class IICefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only…Apr 24, 2024
D-0437-2024Class IIRifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals…Mar 21, 2024

Recent FDA Inspections

DateSiteProductClassificationFEI
May 23, 2014Naples, FLDrugsVoluntary Action Indicated (VAI)3004097115
Dec 23, 2011Naples, FLDrugsVoluntary Action Indicated (VAI)3004097115
Apr 6, 2011Naples, FLDrugsNo Action Indicated (NAI)3004097115
Feb 27, 2009Naples, FLDrugsNo Action Indicated (NAI)3004097115

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 3004097115Naples, FL4May 23, 2014

FDA data resources

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