May 2026 FDA Recall Busulfan by Sagent Pharmaceuticals
D-0539-2026 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Sagent Pharmaceuticals on May 4, 2026 for the product Busulfan. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0539-2026
Failed Impurities/Degradation Specifications
05-04-2026
05-27-2026
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sagent Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
