CLASS III ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalled
Sagent Pharmaceuticals is recalling Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials, distributed nationwide in the US. The recall was initiated on 4 May 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0539-2026
- FDA event ID
- 98883
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Brand
- Busulfan
- Manufacturer
- Sagent Pharmaceuticals
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 4 May 2026
- FDA classified
- 18 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 4 May 2026 | Recall initiated by company | |
| 18 May 2026 | Classified by FDA | +14 days |
| 27 May 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per vial, For IV or IM Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Busulfan recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |