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 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 directly.
Affected Products
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Quantity: 12,584 vials
Why Was This Recalled?
Presence of particulate matter
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report