Busulfan Injections Recalled Due to Failed Impurities/Degradation Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for busulfan injections, 60mg per 10mL (6mg per mL). The affected batches have been identified as Lot 656412 (expires August 2026) and Lot 659646 (expires March 2027), affecting 9528 vials.
• The recall was initiated by Sagent Pharmaceuticals due to failed impurities/degradation specifications, a quality issue that is not likely to cause adverse health consequences.
• Busulfan injections are used to treat chronic myelogenous leukemia.

The FDA has issued a Class III recall for busulfan injections, 60mg per 10mL (6mg per mL), affecting 9528 vials. This medication is being recalled by Sagent Pharmaceuticals based in Schaumburg, Illinois. The recall was initiated on May 4, 2026, and received a Class III classification on May 18, 2026.

The recall was initiated due to failed impurities/degradation specifications, specifically for Lots 656412 and 659646, which expire in August 2026 and March 2027, respectively. A Class III classification means the use of this product is not likely to cause adverse health consequences. Sagent Pharmaceuticals sent out a public notice via letter; no public press release has been issued for this recall.

Busulfan is a prescription medication used to treat chronic myelogenous leukemia. It is used in combination with other drugs to destroy bone marrow and cancer cells before bone marrow transplants. Pharmacists should identify and quarantine the Lots 656412 and 659646, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. May 27, 2026. Accessed May 27, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220077