Soliris (Alexion) – Particle Contamination (2014)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Alexion Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lots: 10002-1, 00006-1, Exp 08/14, 10003A, Exp 11/14, 10004A, Exp 02/15, 10005A, 10005AR, 10007A, 10006A, Exp 07/15, and 10008A, Exp 08/15
Products Sold
Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15
Alexion Pharmaceuticals, Inc. is recalling Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alex due to Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026