Information
Sagent Pharmaceuticals Recalls Busulfan Injection
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0539-2026Drug / Pharmaceutical
Sagent Pharmaceuticals Recalls Busulfan Injection
Sagent Pharmaceuticals · Class III — Regulatory
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
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Sagent Pharmaceuticals initiated a Class III recall of a pharmaceutical product on May 4, 2026 affecting Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. Failed Impurities/Degradation Specifications. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.