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.

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For more information regarding this recall contact Taro Pharmaceuticals, by calling (866) 705-1553 or emailing TaroPVUS@taro.com.