FDAClass III · Drug · Recall D-0539-2026 · Recalled May 27, 2026

Busulfan Injection recall — Sagent Pharmaceuticals

Agency report date: May 27, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Busulfan Injection
Company / brand: Sagent Pharmaceuticals
Lot / serial / date codes: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Distribution: Nationwide within the United States

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Failed Impurities/Degradation Specifications

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class III: not likely to cause adverse health consequences.

Affected product: Busulfan Injection recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0539-2026
Brand: All Sagent Pharmaceuticals recalls
Classification: Class III
Units affected: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Busulfan Injection recall status

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

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Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 25, 2026 at 6:00 PM UTC.

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