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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.
December 28, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-1
Hazard: Presence of foreign substance
November 30, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet
Hazard: Discoloration
November 9, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical
Hazard: Presence of Foreign Substance
October 5, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Labora
Hazard: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
October 5, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laborat
Hazard: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
August 3, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industrie
Hazard: Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
July 20, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutic
Hazard: cGMP - Water leakage
July 13, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Indus
Hazard: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.
Hazard: Failed Tablet/Capsule Specification; oversized tablet found in a bottle
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac
Hazard: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac
Hazard: CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
June 22, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by:
Hazard: Lack of assurance of sterility
June 22, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Nor
Hazard: Lack of assurance of sterility
June 22, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun
Hazard: Lack of assurance of sterility
June 22, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: N
Hazard: Lack of assurance of sterility
June 22, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun
Hazard: Lack of assurance of sterility
May 18, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmace
Hazard: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
May 18, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-c
Hazard: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
April 13, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manu
Hazard: Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
February 23, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St.
Hazard: Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
January 12, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Hazard: Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
November 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactur
Hazard: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
November 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufacture
Hazard: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
November 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister p
Hazard: Failed Moisture Limits
November 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)
Hazard: Failed Moisture Limits
August 18, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKAL
Hazard: Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
May 26, 2021DrugsFDA
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 and Presence of Particulates .
May 19, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmac
Hazard: Presence of foreign substance: identified as activated carbon.
April 21, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactur
Hazard: Microbial Contamination of Non-Sterile Product
April 14, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceuti
Hazard: Failed Moisture Limits: Out of specification for water content