{"url_path":"/fda/drug/recalls/D-0539-2026","section_key":"summary","section_title":"DRUG Recall: Sagent Pharmaceuticals — Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-05-04","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0539-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Sagent Pharmaceuticals"},"word_count":79,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0539-2026\n\n**Recalling firm:** Sagent Pharmaceuticals\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-04\n**Report date:** 2026-05-27\n\n## Product\nBusulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.\n\n## Reason\nFailed Impurities/Degradation Specifications\n\n## Affected lots\nLot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.\n\n## Distribution\nNationwide within the United States"}