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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.
April 14, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, I
Hazard: Failed Impurities/Degradation Specifications
March 10, 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
February 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. C
Hazard: Failed Impurity/Degradation Specifications
February 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun
Hazard: Incorrect Labeling: Incorrect lot number on secondary packaging
October 7, 2020DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx On
Hazard: CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
August 5, 2020DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries
Hazard: Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limit
Hazard: Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0
Hazard: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0
Hazard: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 m
Hazard: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx o
Hazard: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharm
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 coun
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-co
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-c
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Dis
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distr
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
February 6, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries,
Hazard: Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
January 30, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina
Hazard: Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
January 16, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manu
Hazard: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
January 16, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Man
Hazard: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
December 26, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar P
Hazard: Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
August 1, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, I
Hazard: Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
July 25, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by:
Hazard: Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
May 23, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart
Hazard: Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
May 23, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc
Hazard: Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
February 21, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical
Hazard: Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
January 31, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmace
Hazard: Lack Of Assurance Of Sterility
December 20, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz.
Hazard: Microbial Contamination of Non-Sterile Products
May 31, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Lt
Hazard: Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.