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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.

May 17, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88),
Hazard: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
May 17, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88),
Hazard: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
May 17, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88),
Hazard: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
May 17, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
March 29, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun
Hazard: Presence of Particulate Matter
March 8, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical
Hazard: Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
February 8, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles
Hazard: Failed Dissolution Specifications
February 1, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharm
Hazard: Failed Dissolution Specifications; 18 month stability time point
February 1, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88)
Hazard: Failed Dissolution Specifications; 18 month stability time point
November 30, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sampl
Hazard: Failed Stability Specifications: Low Out of Specification results for alcohol content.
October 12, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distribut
Hazard: Failed Dissolution Specifications
September 28, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bott
Hazard: Failed Impurities/Degradation Specifications
September 28, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Man
Hazard: Failed Impurities/Degradation Specifications
September 28, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bo
Hazard: Failed Impurities/Degradation Specifications
September 28, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count
Hazard: Failed Impurities/Degradation Specifications
July 27, 2016DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical In
Hazard: Failed Dissolution Specifications
July 17, 2013DrugsFDA
Sun Pharmaceutical Industries Inc. recalls Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca
Hazard: Crystallization; crystallized nimodipine