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Phenytoin

FDA recalls

4 rows

DateCompany and reasonClass
Oct 26, 2023Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications		Class II · Terminated
May 29, 2023Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)		Class II · Terminated
Feb 6, 2020Taro Pharmaceuticals U.S.A., Inc.
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.		Class I · Terminated
Aug 16, 2013Amneal Pharmaceuticals of New York, LLC.
Failed dissolution specifications; 18 month CRT		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).