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: Out-of-specification results for dissolution (above...
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, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Quantity: 9,056 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Where Was This Sold?
This product was distributed to 3 states: LA, OH, PA
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