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FDAClass III · Drug · Recalled May 27, 2026
Busulfan Injection recall — Sagent Pharmaceuticals
Hazard: Failed Impurities/Degradation Specifications
Class III: not likely to cause adverse health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0539-2026
- Brand
- Sagent Pharmaceuticals
- Classification
- Class III
- Units affected
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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.
Affected products
Companies & origin
- Recalling firm location
- Schaumburg, IL, United States
- Firm address
- 1515 E Woodfield Rd Ste 1100, 60173-6067
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- Distribution
- Nationwide within the United States
- Firm notified the public via
- Letter
- FDA event ID
- 98883
- Recall initiated
- May 4, 2026
- FDA classified
- May 18, 2026
- FDA report date
- May 27, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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