Sagent Pharmaceuticals Busulfan Injection Recall

Source: FDA · United States

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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.