FDAClass III · Drug · Recalled May 27, 2026

Busulfan Injection recall — Sagent Pharmaceuticals

Hazard: Failed Impurities/Degradation Specifications

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0539-2026
Brand: Sagent Pharmaceuticals
Classification: Class III
Units affected: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Busulfan Injection

Companies & origin

Recalling firm location: Schaumburg, IL, United States
Firm address: 1515 E Woodfield Rd Ste 1100, 60173-6067

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Distribution: Nationwide within the United States
Firm notified the public via: Letter
FDA event ID: 98883
Recall initiated: May 4, 2026
FDA classified: May 18, 2026
FDA report date: May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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