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; 18 month CRT
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, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Quantity: 895 - 1000 count bottles
Why Was This Recalled?
Failed dissolution specifications; 18 month CRT
Where Was This Sold?
This product was distributed to 7 states: IL, NH, NJ, NY, OH, RI, TN
About Amneal Pharmaceuticals of New York, LLC.
Amneal Pharmaceuticals of New York, LLC. 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