Quick answers
- Is there a shortage of Mepolizumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mepolizumab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 6, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Mepolizumab?
- 1 company lists prescription products of Mepolizumab in the FDA NDC Directory, including GlaxoSmithKline LLC.
What Mepolizumab is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, powder, for solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Nucala |
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.
- GlaxoSmithKline LLC3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125526 NUCALA | Glaxosmithkline LLC | November 4, 2015 | 9, latest May 22, 2025 2025: Efficacy · 2023: Labeling · 2022: Labeling |
| BLA761122 NUCALA | Glaxosmithkline | June 6, 2019 | 7, latest August 6, 2025 2025: Labeling · 2023: Labeling · 2022: Manufacturing (CMC) |
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.
-
September 6, 2019 · Class II · Terminated · D-1876-2019
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle — Cardinal Health dba Specialty Pharmaceutical Services
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
| FDA labels (SPL) | 0 |
|---|---|
| FDA applications | BLA125526, BLA761122 |
| Active ingredients (FDA) | MEPOLIZUMAB |
Sources
- 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 →