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Sagent Pharmaceuticals Recalls
23 recalls on record · June 26, 2013 to May 27, 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 27, 2026DrugsFDA
Sagent Pharmaceuticals recalls Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,
Hazard: Failed Impurities/Degradation Specifications
June 19, 2024DrugsFDA
Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceu
Hazard: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
June 19, 2024DrugsFDA
Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic
Hazard: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
May 22, 2024DrugsFDA
Sagent Pharmaceuticals recalls MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx on
Hazard: Presence of Particulate Matter: Potential for black particulates in the drug product.
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC
Hazard: Lack of Assurance of Sterility
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplu
Hazard: Lack of Assurance of Sterility
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25
Hazard: Lack of Assurance of Sterility
March 15, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan
Hazard: Labeling: Not elsewhere classified
March 24, 2021DrugsFDA
Sagent Pharmaceuticals Inc recalls Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per ca
Hazard: Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
May 15, 2019DrugsFDA
Sagent Pharmaceuticals Inc recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceutic
Hazard: Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pha
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
August 3, 2016DrugsFDA
Sagent Pharmaceuticals Inc recalls Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preserva
Hazard: Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
March 30, 2016DrugsFDA
Sagent Pharmaceuticals Inc recalls Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SA
Hazard: Cross contamination with other products: metronidazole
March 11, 2015DrugsFDA
Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Inj
Hazard: Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
March 11, 2015DrugsFDA
Sagent Pharmaceuticals Inc recalls Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injec
Hazard: Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
October 22, 2014DrugsFDA
Sagent Pharmaceuticals Inc recalls Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx
Hazard: Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
October 8, 2014DrugsFDA
Sagent Pharmaceuticals Inc recalls Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Ster
Hazard: Lack of Assurance of Sterility; leaking of premix bags
June 26, 2013DrugsFDA
Sagent Pharmaceuticals Inc recalls VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx
Hazard: CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.