Busulfan Injection, Solution, Concentrate
FDA Recall NDC 25021-241
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Busulfan (NDC 25021-241). A significant event, classified as Class III, was initiated on May 04, 2026 by Sagent Pharmaceuticals. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications
May 04, 2026
May 27, 2026
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Recall Profile & Regulatory Data
Event ID
98883
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Sagent Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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.
Batch or Lot Expiration Information
Lot# : 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Affected Packages Involved in this Recall
25021-241-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
