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# Taro Pharma Recalls Phenytoin Oral Suspension
- URL: https://www.fdaweb.com/taro-pharma-recalls-phenytoin-oral-suspension/
- Published: 2020-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:04:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146157

Taro Pharmaceuticals has recalled two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspend when shaken, which could result in under- or over-dosing, according to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-phenytoin-oral-suspension-usp-125-mg5ml?ref=fdaweb.com). Phenytoin is indicated for treating tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.

The population at risk due to the recall are primarily infants and young children, the notice says, because an inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For some patients, a drop in their phenytoin blood levels could result in life-threatening status epilepticus, which would require immediate emergency room treatment, it says.