Sun Pharmaceutical Industries, Inc.

FDA Regulatory Profile

Summary

Total Recalls
135 (3 Class I)
510(k) Clearances
1
Inspections
72
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-0607-2026Class IIBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose AmpuMay 29, 2026
D-0598-2026Class IIXyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: May 22, 2026
D-0599-2026Class IIXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: May 22, 2026
D-0580-2026Class IDOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, May 12, 2026
D-0476-2026Class IIFluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, OntaMarch 25, 2026
D-0477-2026Class IIFluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, OntaMarch 25, 2026
D-0475-2026Class IIFluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, OntaMarch 25, 2026
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-0149-2026Class IILisdexamfetamine Dimesylate Capsules, 60 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-0150-2026Class IILisdexamfetamine Dimesylate Capsules, 70 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-0146-2026Class IILisdexamfetamine Dimesylate Capsules, 30 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-0144-2026Class IILisdexamfetamine Dimesylate Capsules, 10 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

Recent 510(k) Clearances

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