Busulfan Injection, 60 mg per 10 mL (6 mg per mL)

Sagent Pharmaceuticals has recalled Busulfan Injection, 60 mg per 10 mL (6 mg per mL), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 27, 2026 and was initiated on May 4, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Busulfan Injection, 60 mg per 10 mL (6 mg per mL), with approximately Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. affected. The company behind the recall is Sagent Pharmaceuticals, based in Schaumburg, IL. The FDA describes the product as: “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.”

Why was Busulfan Injection, 60 mg per 10 mL (6 mg per mL) recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurities/Degradation Specifications.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Busulfan Injection, 60 mg per 10 mL (6 mg per mL), compare it against the product description and identifying codes (Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Sagent Pharmaceuticals or your local health authority.

About this recall

This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.