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) Recalled by Alexion Pharmaceuticals, Inc. Due to Presence of Particulate Matter: Product failed the appearance...
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), 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: 96,506 vials
Why Was This Recalled?
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
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