Home / Recalls / Sagent Pharmaceuticals / D-0539-2026

D-0539-2026 Class III Ongoing

Recalled by Sagent Pharmaceuticals — Schaumburg, IL

Recall Details

Product Type
Drugs
Report Date
May 27, 2026
Initiation Date
May 4, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.

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  • D-0499-2024 Class II — MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg p (April 25, 2024)
  • D-0937-2023 Class II — Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intr (July 11, 2023)
  • D-0936-2023 Class II — Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, label (July 11, 2023)
  • D-0935-2023 Class II — Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. f (July 11, 2023)
  • D-0763-2023 Class II — Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmace (May 19, 2023)
  • D-0764-2023 Class II — Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. f (May 19, 2023)
  • D-0762-2023 Class II — Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmace (May 19, 2023)
  • D-0435-2023 Class II — Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Via (February 28, 2023)