Quick answers
- What is Sargramostim used for?
- The FDA-approved label (Leukine, Partner Therapeutics, Inc., December 6, 2024) says: “LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sargramostim have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sargramostim?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sargramostim been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 23, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Sargramostim?
- 1 company lists prescription products of Sargramostim in the FDA NDC Directory, including Partner Therapeutics, Inc..
What Sargramostim is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). …
— FDA label: Leukine, Partner Therapeutics, Inc., effective December 6, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Leukine |
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.
- Partner Therapeutics, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103362 LEUKINE | Berlex Labs | March 5, 1991 | 8, latest May 5, 2022 2022: Labeling · 2018: Efficacy · 2017: Labeling |
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.
-
June 23, 2021 · Class III · Terminated · D-0655-2021
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5 — Partner Therapeutics Inc
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) | 208083, 315199 |
|---|---|
| SPL set ID of the quoted label | bb9a3820-f31a-4dd9-bef4-97094c01a398 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA103362 |
| Active ingredients (FDA) | SARGRAMOSTIM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Leukine, Partner Therapeutics, Inc., effective December 6, 2024; 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 →