Sagent Pharmaceuticals Busulfan Injection Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 10, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Sagent Pharmaceuticals initiated a voluntary recall of Busulfan Injection after the products failed impurities/degradation specifications.
Which Products Are Affected
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, NDC 25021-241-10. Affected lots are 656412 (Exp. Date 08/31/2026, 6,200 vials) and 659646 (Exp. Date 03/31/2027, 3,328 vials). Distributed nationwide within the United States. Recall number D-0539-2026.
What You Should Do
The recall is ongoing and was initiated via letter. Consumers and healthcare providers should refer to the recalling firm for further guidance.
Why This Matters
This is a Class III recall affecting 9,528 vials distributed across the United States.
Source
FDA recall D-0539-2026, Sagent Pharmaceuticals, Schaumburg, IL.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (827 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to June 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.