Sun Pharmaceutical Industries recalls
FDA enforcement reports naming SUN PHARMACEUTICAL INDUSTRIES INC as the recalling firm.
- Recall reports
- 138
- Class I (serious)
- 3
- Most recent report
- Aug 26, 2026
- Aug 26, 2026Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro P…Drug · SUN PHARMACEUTICAL INDUSTRIES INCCGMP Deviations; black spots found on tablets from burnt excipient during manufacturingClass II
- Jul 8, 2026Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle,…Drug · SUN PHARMACEUTICAL INDUSTRIES INCFailed Impurities/Degradation SpecificationsClass III
- Jul 1, 2026Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, MfdDrug · SUN PHARMACEUTICAL INDUSTRIES INCLabeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.Class II
- Jun 17, 2026DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose via…Drug · SUN PHARMACEUTICAL INDUSTRIES INCPresence of Particulate matter: Particulate matter identified as glass.Class I
- Jun 17, 2026Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Sin…Drug · SUN PHARMACEUTICAL INDUSTRIES INCPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solutionClass II
- Jun 10, 2026Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manu…Drug · SUN PHARMACEUTICAL INDUSTRIES INCLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaClass II
- Jun 10, 2026Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manu…Drug · SUN PHARMACEUTICAL INDUSTRIES INCLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaClass II
- Apr 22, 2026Fluocinonide, USP, 0Drug · SUN PHARMACEUTICAL INDUSTRIES INCFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Class II
- Apr 22, 2026Fluocinonide, USP, 0Drug · SUN PHARMACEUTICAL INDUSTRIES INCFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Class II
- Apr 22, 2026Fluocinonide, USP, 0Drug · SUN PHARMACEUTICAL INDUSTRIES INCFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Class II
- Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd
- Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle…
- Fluocinolone Acetonide Solution Topical Solution USP, 0
- Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactur…
- Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactur…
- Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun…
- Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactu…
- Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles
- Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles
- Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufact…
- Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle,…
- Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent,…
- Xelpros (latanoprost ophthalmic emulsion) 0
- Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmac…
- Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for:…
- Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for:…
- Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manu…
- Mesalamine Delayed-Release Tablets, USP 1
- Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed…
- Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distribute…
- Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by:…
- Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by:…
- Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceu…
- Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceut…
- Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceut…
- Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 T…
- Zolpidem Tartrate Extended-Release Tablets, USP 12
- Zolpidem Tartrate Extended-Release Tablets, USP 6
- Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun…
- buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, D…
- Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Su…
- Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: S…
- Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, R…
- Cequa (cyclosporine ophthalmic solution) 0
- Dofetilide Capsules 500 mcg (0
- Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manuf…
- Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0
- Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutic…
- Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceu…
- Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun…
- buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only…
- Fyremadel (ganirelix acetate) injection, 250 mcg/0
- Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Flipto…
- Dofetilide Capsules, 500 mcg (0
- Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg
- Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 5…
- Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juic…
- Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Di…
- Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bo…
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bot…
- Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed…
- Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial,…
- Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distrib…
- Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx…
- Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx…
- Clonazepam Orally Disintegrating Tablets, USP, 0
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/m…
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/…
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/…
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/…
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150…
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-cou…
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx…
- Cequa (cyclosporine ophthalmic solution) 0
- Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg
- Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutic…
- Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx…
- Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx L…
- AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets,…
- Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended…
- Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis…
- Cequa (cyclosporine ophthalmic solution) 0
- Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx…
- Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl
- Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only…
- Ganirelix Acetate Injection, 250 mcg/0
- Cequa (cyclosporine ophthalmic solution) 0
- Pantoprazole Sodium for Injection 40mg/vial For I
- Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Sing…
- RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5…
- Clonazepam Orally Disintegrating Tablets, USP, 0
- Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Su…
- Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Labor…
- Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Labor…
- Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (…
- Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vi…
- Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple D…
- Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (6…
- Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release…
- Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets…
- Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Releas…
- Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets,…
- BromSite (bromfenac ophthalmic solution) 0
- LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distribu…
- Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized…
- Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilize…
- Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx o…
- Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by:…
- Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count…
- Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl
- Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle…
- Azelastine HCl Nasal Solution (Nasal Spray) 0
- DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use V…
- Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl
- Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactur…
- Olanzapine Tablets, 7
- Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-c…
- Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-c…
- Olanzapine Tablets, 2
- Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use O…
- Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Di…
- Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62…
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-73…
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, R…
- KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60…
- Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (N…
- Carvediol Tablets, USP, 12
- Carvediol Tablets, USP, 6
- Carvediol Tablets , USP, 3
- buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Dis…
- Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose C…
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