Sagent Pharmaceuticals — Busulfan Injection recall — Low risk

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Sagent Pharmaceuticals

Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
Refunds don't require a receipt, and you don't need proof of purchase.
FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14

Low risk Filed 2026-05-27

Failed Impurities/Degradation Specifications

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.

Check these codes: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.

Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. · distributed nationwide within the united states Recall D-0539-2026 on FDA.gov ↗

Watch Sagent Pharmaceuticals for new recalls

One email per recall. Nothing else, ever.