Quick answers
- What is Soliris?
- Soliris is a brand name of Eculizumab-aagh, a prescription medicine. The FDA NDC Directory lists 1 Soliris product in 1 strength and form.
- Who makes Soliris?
- Alexion Pharm holds the FDA application for Soliris (BLA125166, approved March 16, 2007).
- Is there a generic or store brand of Soliris?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Soliris product. Ask your pharmacist whether one is right for you.
- Has Soliris been recalled?
- FDA enforcement reports list 2 recalls of Soliris products; the newest started June 2, 2014. A recall usually concerns specific lots, not every product.
What Soliris is
Each Soliris product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Eculizumab-aagh · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| eculizumab 300 mg/30 mL injection, solution, concentrate (intravenous) | Soliris | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Eculizumab-aagh →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125166 | Alexion Pharm | March 16, 2007 | 1 |
Companies that list Soliris
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Soliris products.
- Alexion Pharmaceuticals Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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.
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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.