Prescription medicine
Plerixafor Brand names: Mozobil
Plerixafor (Mozobil) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 11 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the plerixafor FDA label on DailyMed (effective November 19, 2025, Fresenius Kabi Usa, LLC); the NDA 22311 record on Drugs@FDA; every plerixafor label on DailyMed.
Highlights of the record
FDA label of November 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePlerixafor is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).
Forms and strengths
- 20 mg/ml
- 24 mg/1.2ml
Injection (solution); solution; injection.
On the market
- Earliest approval on file
- December 15, 2008 Mozobil, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first July 24, 2023; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 11 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 2 since 2016 0 Class I among all firms' recalls; latest September 1, 2016
- FAERS reports
- 1,464 through July 30, 2026
What is plerixafor used for?
From the label: indications and usagePlerixafor is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Plerixafor, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.
FDA pharmacologic class: Hematopoietic Stem Cell Mobilizer.
Source: FDA drug label (Plerixafor), NDA022311 (Genzyme), as published by Fresenius Kabi Usa, LLC, effective November 19, 2025 (SPL set 5d670cb4-163e-498c-b5fa-c193ea9d55c0), via openFDA; the full label on DailyMed
Is there a generic for plerixafor (Mozobil)?
The FDA approved the first generic plerixafor on July 24, 2023. 9 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists plerixafor from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2008 earliest approval on file
- 2023 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is plerixafor in shortage?
No plerixafor presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated March 13, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Plerixafor, Injection, 24 mg per 1.2 mL (20 mg per mL) (NDC 65219-284-12) | Fresenius Kabi USA, LLC | To Be Discontinued | March 13, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has plerixafor been recalled?
The FDA's Enforcement Report lists 2 recalls naming plerixafor since 2016: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 1, 2016 | Class III | Sanofi-Aventis U.S. LLC | Labeling: Incorrect or Missing Package Insert |
| August 4, 2016 | Class III | Genzyme Corporation / Genzyme Biosurgery | Labeling: Incorrect or Missing Lot and/or Exp. Date |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the plerixafor label say about other medicines?
The plerixafor label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Filgrastim | warnings and precautions | Tumor cells may be released from marrow during HSC mobilization with plerixafor and filgrastim. |
Source: FDA drug label (Plerixafor), NDA022311 (Genzyme), as published by Fresenius Kabi Usa, LLC, effective November 19, 2025 (SPL set 5d670cb4-163e-498c-b5fa-c193ea9d55c0), via openFDA; the full label on DailyMed
What do FAERS reports show for plerixafor?
The FDA Adverse Event Reporting System holds 1,464 reports that list plerixafor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 243 are coded as a death and 471 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Plerixafor side effects
- the label's list beside FAERS reports
- Plerixafor shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other