Lupin Pharmaceuticals Inc.

FDA Regulatory Profile

Summary

Total Recalls
119 (5 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0220-2026Class IIGanirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' November 13, 2025
D-0227-2026Class IISertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin PhNovember 5, 2025
D-0542-2025Class IIAmlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured July 2, 2025
D-0537-2025Class IIclomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite June 27, 2025
D-0532-2025Class IILisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: LuJune 20, 2025
D-0377-2025Class IIclomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin PApril 10, 2025
D-0167-2025Class IILevothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: LupiDecember 20, 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) October 23, 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)October 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) 5October 23, 2024
D-0648-2024Class IICefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin PharmaAugust 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 forMay 8, 2024
D-0496-2024Class IICefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, ManuApril 24, 2024
D-0497-2024Class IICefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, ManuApril 24, 2024
D-0437-2024Class IIRifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, InMarch 21, 2024
D-0337-2024Class IIVoriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing DireFebruary 5, 2024
D-0283-2024Class IIRifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, InJanuary 5, 2024
D-0284-2024Class IIRifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, IncJanuary 5, 2024
D-0274-2024Class IICefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin PharmaceuticaJanuary 3, 2024