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Sagent Pharmaceuticals

Generic drug maker in United States. FDA records under 5 spellings of its name, each linked to the record.

  • Drug applications: 94
  • Drug recalls: 23

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
May 4, 2026Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195Class III · Failed Impurities/Degradation SpecificationsDrug recalls
May 28, 2024Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, Class I · Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Drug recalls
May 28, 2024Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL Class I · Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Drug recalls
Apr 25, 2024MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENTClass II · Presence of Particulate Matter: Potential for black particulates in the drug product.Drug recalls
Jul 11, 2023Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in InClass II · Lack of Assurance of SterilityDrug recalls
Jul 11, 2023Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Class II · Lack of Assurance of SterilityDrug recalls
Jul 11, 2023Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b)Class II · Lack of Assurance of SterilityDrug recalls

Names and Identifiers

Appears as
SAGENT PHARMS INCSAGENT PHARMSSagent Pharmaceuticals IncSagent PharmaceuticalsSAGENT
Wikidata
Q28401584

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.