Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fosphenytoin Sodium Injection Recalled by Amneal Pharmaceuticals LLC Due to Presence of Particulate Matter
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 Amneal Pharmaceuticals LLC directly.
Affected Products
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Quantity: 14,000 vials
Why Was This Recalled?
Presence of Particulate Matter
Where Was This Sold?
This product was distributed to 5 states: MS, NC, OH, TX, UT
About Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC 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