SUN PHARMACEUTICAL INDUSTRIES INC

FDA Regulatory Profile

Summary

Total Recalls
128 (2 Class I)
510(k) Clearances
1
Inspections
71
Compliance Actions
5

Known Names

sun pharmaceutical industries, -sun pharmaceutical industries, sun pharmaceutical industries limited (formerly known as sun pharmaceutical medicare limited), sun pharmaceutical industries limited (formarly known as sun pharmaceutical medicare limited)

Recent Recalls

NumberClassProductDate
D-0342-2026Class IIDiclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., BramptoJanuary 27, 2026
D-0256-2026Class IIIFluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro December 30, 2025
D-0257-2026Class IIIClindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, MfNovember 26, 2025
D-0144-2026Class IILisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0146-2026Class IILisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0149-2026Class IILisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0148-2026Class IILisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0150-2026Class IILisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0147-2026Class IILisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0145-2026Class IILisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM LaOctober 28, 2025
D-0658-2025Class IIKit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun PharmaceuticaSeptember 3, 2025
D-0574-2025Class IISpironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 110August 5, 2025
D-0516-2025Class IILisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM LJune 16, 2025
D-0312-2025Class IIIGabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 100March 4, 2025
D-0311-2025Class IIIGabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 10March 4, 2025
D-0249-2025Class IIMorphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm February 6, 2025
D-0597-2024Class IINitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, ManufacturedJuly 9, 2024
D-0582-2024Class IIDecitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx OJuly 2, 2024
D-0502-2024Class IIIXelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, ManufacturedApril 22, 2024
D-0493-2024Class IIAmphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical IndusApril 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K241358BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EJune 13, 2024