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SUN PHARMACEUTICAL INDUSTRIES Recalls
137 recalls on record · July 17, 2013 to July 8, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 20, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
March 6, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical I
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceuti
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceut
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: S
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, I
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
December 20, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. C
Hazard: Failed Impurities/Degradation Specifications
December 13, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical
Hazard: Failed Dissolution Specifications
November 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc
Hazard: Failed Impurities/Degradation Specifications.
November 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.
Hazard: Failed Impurities/Degradation Specifications.
October 25, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharm
Hazard: Failed Dissolution Specifications
September 27, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx
Hazard: Subpotent: Out of Specification result observed for low assay
August 16, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su
Hazard: Out of Specification result observed in content uniformity testing
August 2, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc.
Hazard: Presence of Foreign Substance: Metal embedded in a tablet.
July 26, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#
Hazard: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
July 19, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0
Hazard: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
July 5, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury,
Hazard: Subpotent drug
June 14, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Hazard: CGMP Deviations
May 31, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceuti
Hazard: Failed Dissolution Specifications; during stability testing
May 3, 2023DrugsFDA
Sun Pharmaceutical Industries Ltd. recalls Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutane
Hazard: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
April 19, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packag
Hazard: Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
March 29, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,
Hazard: Failed Content Uniformity Specifications
February 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmace
Hazard: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.