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Sun Pharmaceutical Industries Inc FDA Recalls
94 recalls on file across drugs, 1 of them Class I and 32 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., HaClass IIAug 3, 2026CGMP Deviations; black spots found on tablets from burnt exc |
| Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476Class IIJun 17, 2026Labeling: Label Mix-up: 10mg Perampanel CIII tablet was foun |
| Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories,Class IIIJun 1, 2026Failed Impurities/Degradation Specifications |
| Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouClass IIMay 29, 2026Presence of Foreign Substance:This recall has been initiated |
| Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories IncClass IIMay 22, 2026Labeling: Not Elsewhere Classified. This recall has been ini |
| Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories IncClass IIMay 22, 2026Labeling: Not Elsewhere Classified. This recall has been ini |
| DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, ManufactureClass IMay 12, 2026Presence of Particulate matter: Particulate matter identifie |
| Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,Class IIMar 25, 2026Failed Viscosity Specifications: Out of Specification resul |
| Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,Class IIMar 25, 2026Failed Viscosity Specifications: Out of Specification resul |
| Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,Class IIMar 25, 2026Failed Viscosity Specifications: Out of Specification resul |
| Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada LClass IIJan 27, 2026Failed Viscosity Specifications: Out of Specification (OOS) |
| Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.Class IIIDec 30, 2025Failed Impurities/Degradation Specifications: Out of specifi |
| Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro PharmaceClass IIINov 26, 2025Failed Impurities/Degradation: Out of Specification results |
| Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New BrunClass IIOct 28, 2025Failed Dissolution Specifications: An out of specification r |
| Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. BClass IISep 3, 2025Failed Dissolution Specifications-Out of Specification (OOS) |
| Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, PhilaClass IIAug 5, 2025Presence of foreign substance: identified as aluminum. |
| Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New BruClass IIJun 16, 2025Failed Dissolution Specifications: An out of specification r |
| Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDClass IIIMar 4, 2025Cross Contamination |
| Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDCClass IIIMar 4, 2025Cross Contamination |
| Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., NClass IIFeb 6, 2025Failed Dissolution Specifications |
| Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak LaboratoClass IIJul 9, 2024Failed Dissolution Specifications |
| Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose ViaClass IIJul 2, 2024CGMP Deviations: Out of Specification for Total Aerobic Micr |
| Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun PharmaceutiClass IIIApr 22, 2024Failed Release Testing: Out of specification for particulate |
| Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. CranburyClass IIApr 19, 2024Out of specification for assay |
| Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38Class IIMar 4, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38Class IIMar 4, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical IClass IIFeb 5, 2024Failed Dissolution Specifications: Out of specification for |
| Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Class IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: SClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-Class IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, Class IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical IndustrieClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, Class IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun PharmaceutiClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun PharmaceutClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, IClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,Class IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical IndustriClass IIJan 18, 2024CGMP Deviations: Microbial contamination was reported in sta |
| Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. CClass IIDec 4, 2023Failed Impurities/Degradation Specifications |
| buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun PharmaceuticalClass IIINov 22, 2023Failed Dissolution Specifications |
| Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, IncClass IIOct 20, 2023Failed Impurities/Degradation Specifications. |
| Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Class IIOct 20, 2023Failed Impurities/Degradation Specifications. |
| Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun PharmClass IIIOct 4, 2023Failed Dissolution Specifications |
| Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), RxClass IIISep 7, 2023Subpotent: Out of Specification result observed for low assa |
| Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, SuClass IIIJul 18, 2023Out of Specification result observed in content uniformity t |
| Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc.Class IIJul 13, 2023Presence of Foreign Substance: Metal embedded in a tablet. |
| Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0Class IIJul 10, 2023Failed Impurities: Out of Specification (OOS) result observe |
| Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#Class IIIJul 5, 2023Superpotent Drug: Out of Specification (OOS) results observe |
| Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, Class IIMay 30, 2023Subpotent drug |
| buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun PharmaceutiClass IIMay 9, 2023Failed Dissolution Specifications; during stability testing |
| Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.Class IIMay 3, 2023CGMP Deviations |
| Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packagClass IIIMar 29, 2023Failed Impurities/Degradation Specifications: Above the spec |
| Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,Class IIIMar 9, 2023Failed Content Uniformity Specifications |
| Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun PharmaceClass IIJan 13, 2023Failed Impurity (Deacetyl Diltiazem Hydrochloride) specifica |
| Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-1Class IIDec 1, 2022Presence of foreign substance |
| Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun PharmaceuticalClass IIOct 18, 2022Presence of Foreign Substance |
| Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet Class IIJul 25, 2022Discoloration |
| Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical IndustrieClass IIJun 27, 2022Failed Dissolution Specifications: Failure occurred during r |
| Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun PharmaceuticClass IIJun 21, 2022cGMP - Water leakage |
| Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm LaboratClass IIIJun 21, 2022Superpotent Drug: Out of specification for assay at the 12-m |
| Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm LaboraClass IIIJun 21, 2022Superpotent Drug: Out of specification for assay at the 12-m |
| Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun PharmacClass IIJun 10, 2022Lack of Assurance of Sterility: Manufacturing deviation whic |
| Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.Class IIJun 3, 2022Failed Tablet/Capsule Specification; oversized tablet found |
| Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun PharmacClass IIJun 3, 2022CGMP Deviations: lots made with same active pharmaceutical i |
| Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical IndusClass IIJun 3, 2022CGMP Deviations: Manufacturing deviations were reported due |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: NClass IIMay 6, 2022Lack of assurance of sterility |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: SunClass IIMay 6, 2022Lack of assurance of sterility |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Class IIMay 6, 2022Lack of assurance of sterility |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: NorClass IIMay 6, 2022Lack of assurance of sterility |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Class IIMay 6, 2022Lack of assurance of sterility |
| buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-cClass IIIApr 29, 2022Presence Of Foreign Substance: Customer complaint for the pr |
| buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun PharmaceClass IIIApr 29, 2022Presence Of Foreign Substance: Customer complaint for the pr |
| Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, ManuClass IIIApr 1, 2022Subpotent Drug and Presence of Particulate Matter: low out-o |
| Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Class IIFeb 7, 2022Foreign Matter identified as stainless steel microscopic wea |
| Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, ManufacturClass IIOct 25, 2021Incorrect Product Formulation: An incorrect grade of Crospov |
| Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, ManufactureClass IIOct 25, 2021Incorrect Product Formulation: An incorrect grade of Crospov |
| Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJClass IIOct 22, 2021Failed Tablet/Capsule Specifications: Out of Specification r |
| Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)Class IIIOct 12, 2021Failed Moisture Limits |
| AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister pClass IIIOct 12, 2021Failed Moisture Limits |
| Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALClass IIJul 29, 2021Presence of Forein Tablets/Capsules; Venlafaxine Tablets, US |
| Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), RxClass IIIMay 7, 2021Subpotent and Presence of Particulates . |
| Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun PharmacClass IIMay 4, 2021Presence of foreign substance: identified as activated carbo |
| Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, ManufacturClass IIMar 31, 2021Microbial Contamination of Non-Sterile Product |
| Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun PharmaceutiClass IIIMar 25, 2021Failed Moisture Limits: Out of specification for water conte |
| Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, IClass IIMar 15, 2021Failed Impurities/Degradation Specifications |
| Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), RxClass IIIFeb 22, 2021Subpotent |
| Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. CClass IIIFeb 5, 2021Failed Impurity/Degradation Specifications |
| Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Class IIIJan 11, 2021Incorrect Labeling: Incorrect lot number on secondary packag |