FDA Drug Recalls

Recalls / Generics / Phenytoin Sodium

Phenytoin Sodium

5 FDA drug recalls involving generic “Phenytoin Sodium.

DateClassProductFirm
2023-10-27Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC BAmneal Pharmaceuticals of New York, LLC
2023-05-30Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal PharAmneal Pharmaceuticals of New York, LLC
2022-11-14Class IIIPhenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42Acella Pharmaceuticals, LLC
2022-11-14Class IIIPhenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 421Acella Pharmaceuticals, LLC
2013-08-17Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 651Amneal Pharmaceuticals of New York, LLC.