Phenytoin Oral Suspension Recalled Due to Potential for Inaccurate Dosing

Taro Pharmaceuticals announced the voluntary recall of 2 lots of Phenytoin Oral Suspension 125mg/mL packaged in 237mL bottles that may not resuspend properly when shaken, which can potentially result in under or overdosing.

The 2 recalled lots of Phenytoin Oral Suspension 125mg/mL, NDC# 51672-4069-1 include the following: 

• Lot Number 327874; Expiration Date of December 2020; Distributed between May 3, 2019 and July 5, 2019.
• Lot Number 327876; Expiration Date of December 2020; Distributed between July 1, 2019 and August 21, 2019.

Phenytoin is indicated for the treatment of tonic-clonic and psychomotor seizures. The recall primarily affects infants and young children that may receive inaccurate dosing. Patients exposed to a lower dose may experience severe or repeated breakthrough seizures, and a drop in phenytoin blood levels could lead to life-threatening status epilepticus. 

At this time, the Company has not received any adverse event reports related to this recall. Adverse reactions may be reported to the FDA’s MedWatch program.

For more information regarding this recall contact Taro Pharmaceuticals, by calling (866) 705-1553 or emailing [email protected].