SUN PHARMACEUTICAL INDUSTRIES INC Provisional
FDA Flags (85)
Class III RecallJul 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories,
Classification: Class III
Class II RecallJul 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476
Classification: Class II
Class II RecallJun 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pou
Classification: Class II
Class I RecallJun 2026
SUN PHARMACEUTICAL INDUSTRIES INC
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufacture
Classification: Class I
Class II RecallJun 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc
Classification: Class II
Class II RecallJun 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc
Classification: Class II
Class II RecallApr 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Classification: Class II
Class II RecallApr 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Classification: Class II
Class II RecallApr 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Classification: Class II
Class II RecallFeb 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L
Classification: Class II
Class III RecallJan 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.
Classification: Class III
Class III RecallJan 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmace
Classification: Class III
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallNov 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Classification: Class II
Class II RecallSep 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. B
Classification: Class II
Class II RecallAug 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phila
Classification: Class II
Class II RecallJul 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru
Classification: Class II
Class III RecallApr 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC
Classification: Class III
Class III RecallApr 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND
Classification: Class III
Class II RecallMar 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., N
Classification: Class II
Class II RecallJul 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborato
Classification: Class II
Class II RecallJul 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Via
Classification: Class II
Class III RecallMay 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceuti
Classification: Class III
Class II RecallMay 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury
Classification: Class II
Class II RecallMar 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Classification: Class II
Class II RecallMar 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Classification: Class II
Class II RecallMar 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical I
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, I
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceuti
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: S
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceut
Classification: Class II
Class II RecallJan 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-
Classification: Class II
Class II RecallDec 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. C
Classification: Class II
Class III RecallDec 2023
SUN PHARMACEUTICAL INDUSTRIES INC
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical
Classification: Class III
Class II RecallNov 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.
Classification: Class II
Class II RecallNov 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc
Classification: Class II
Class III RecallOct 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharm
Classification: Class III
Class III RecallSep 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx
Classification: Class III
Class III RecallAug 2023
SUN PHARMACEUTICAL INDUSTRIES INC
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su
Classification: Class III