Quick answers
- What is Busulfan used for?
- The FDA-approved label (Myleran, Waylis Therapeutics LLC, January 8, 2025) says: “MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Busulfan have a boxed warning?
- Yes. The FDA label for Myleran has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Busulfan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Busulfan been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 4, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Busulfan?
- 8 companies list prescription products of Busulfan in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., Accord Healthcare Inc. and Sagent Pharmaceuticals.
What Busulfan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
— FDA label: Myleran, Waylis Therapeutics LLC, effective January 8, 2025. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
9 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Injection, solution, concentrate · Tablet, film coated |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Myleran |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Meitheal Pharmaceuticals Inc.2 products
- Accord Healthcare Inc.1 product
- Sagent Pharmaceuticals1 product
- Hospira, Inc.1 product
- Waylis Therapeutics LLC1 product
- Eugia US LLC1 product
- Pharmascience Inc.1 product
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA009386 MYLERAN | Waylis Therap | June 26, 1954 | 18, latest December 24, 2003 2003: Labeling · 2003: Labeling · 2003: Manufacturing (CMC) |
Generic approvals (6)
- ANDA207050Pharmascience Inc · March 24, 2017
- ANDA209580Amneal · December 18, 2017
- ANDA205672Hospira · July 31, 2018
- ANDA210148Accord Hlthcare Inc · February 22, 2019
- ANDA212127Meitheal · October 23, 2020
- ANDA215102Eugia Pharma · June 25, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 4, 2026 · Class III · Ongoing · D-0539-2026
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. — Sagent Pharmaceuticals
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 105551, 197422, 253113 |
|---|---|
| SPL set ID of the quoted label | 2da33e5b-dcfb-4cdf-b163-50398e42f41c |
| FDA labels (SPL) | 9 |
| FDA applications | NDA009386, 6 ANDA |
| Active ingredients (FDA) | BUSULFAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Myleran, Waylis Therapeutics LLC, effective January 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →