SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC appears in FDA public data with 137 recalls — including 3 Class I (most serious) —, 1 510(k) clearance, 72 FDA inspections, and 5 compliance actions on record. Its most recent recall (D-0628-2026, Class II) was initiated on June 17, 2026. Its most recent 510(k) clearance was granted on June 13, 2024.
Summary
- Total Recalls
- 137 (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
| Number | Class | Product | Date |
|---|---|---|---|
| D-0628-2026 | Class II | Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haif | June 17, 2026 |
| D-0654-2026 | Class III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed b | June 1, 2026 |
| D-0607-2026 | Class II | Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampu | May 29, 2026 |
| D-0599-2026 | Class II | Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: | May 22, 2026 |
| D-0598-2026 | Class II | Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: | May 22, 2026 |
| D-0580-2026 | Class I | DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, | May 12, 2026 |
| D-0475-2026 | Class II | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Onta | March 25, 2026 |
| D-0476-2026 | Class II | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Onta | March 25, 2026 |
| D-0477-2026 | Class II | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Onta | March 25, 2026 |
| D-0342-2026 | Class II | Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampto | January 27, 2026 |
| D-0256-2026 | Class III | Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro | December 30, 2025 |
| D-0257-2026 | Class III | Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mf | November 26, 2025 |
| D-0146-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0147-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0144-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0150-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0148-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0145-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0149-2026 | Class II | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM La | October 28, 2025 |
| D-0658-2025 | Class II | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutica | September 3, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | June 13, 2024 |