Quick answers
- What is Eculizumab-aagh used for?
- The FDA-approved label (Soliris, Alexion Pharmaceuticals Inc., July 8, 2026) says: “SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eculizumab-aagh have a boxed warning?
- Yes. The FDA label for Soliris has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Eculizumab-aagh?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eculizumab-aagh been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 2, 2014 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Eculizumab-aagh?
- 3 companies list prescription products of Eculizumab-aagh in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc., Alexion Pharmaceuticals Inc. and Amgen, Inc.
What Eculizumab-aagh is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). …
— FDA label: Soliris, Alexion Pharmaceuticals Inc., effective July 8, 2026. Read the full label on DailyMed →
The FDA has 3 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 →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Teva Pharmaceuticals USA, Inc.1 product
- Alexion Pharmaceuticals Inc.1 product
- Amgen, Inc1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125166 SOLIRIS | Alexion Pharm | March 16, 2007 | 27, latest October 21, 2026 2026: REMS · 2026: Labeling · 2026: REMS |
| BLA761333 BKEMV | Amgen Inc | May 28, 2024 | 7, latest June 29, 2026 2026: Bioequivalence · 2026: REMS · 2025: Labeling |
| BLA761340 EPYSQLI | Samsung Bioepis Co Ltd | July 19, 2024 | 10, latest June 29, 2026 2026: Bioequivalence · 2026: REMS · 2026: REMS |
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 2, 2014 · Class I · Terminated · D-1512-2014
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. — Alexion Pharmaceuticals, Inc.
-
November 4, 2013 · Class I · Terminated · D-1049-2014
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC — Alexion Pharmaceuticals, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Soliris, Alexion Pharmaceuticals Inc., effective July 8, 2026; 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 →