Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only Recalled by Alexion Pharmaceuticals, Inc. Due to Presence of Particulate Matter: Failed the appearance test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alexion Pharmaceuticals, Inc. directly.
Affected Products
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 3 25682-001-01 6.
Quantity: 21,661 vials
Why Was This Recalled?
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report