Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Extended Phenytoin Sodium Capsules Recalled by Amneal Pharmaceuticals of New York, LLC Due to Failed Dissolution Specifications
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 of New York, LLC directly.
Affected Products
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Quantity: 9,263 100-count bottles
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York, LLC has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report