Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fosphenytoin Sodium Injection Recalled by Fresenius Kabi USA, LLC Due to Presence of Particular Matter: Potential glass delamination and...
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 Fresenius Kabi USA, LLC directly.
Affected Products
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Quantity: 728,880 vials
Why Was This Recalled?
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report