Fosphenytoin recalls

The FDA has published 6 recalls involving Fosphenytoin since 2012. The latest was reported on 4 Apr 2018. Most were for particulate matter. Fresenius Kabi USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 4 Apr 2018

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why fosphenytoin is recalled

Particulate Matter6100%

Companies

Brands

Fosphenytoin233%
Fosphenytoin Sodium233%

By year

2018117%
2017117%
2014233%
2012233%

All fosphenytoin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018Drug	CLASS II	Fosphenytoin Sodium Injection, USP 500 mg PE* recalled	Amneal Pharmaceuticals	Particulate Matter	Nationwide
22 Nov 2017Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalled	Amneal Pharmaceuticals	Particulate Matter	5 states
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Aug 2012Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide
8 Aug 2012Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide

Should you stop taking Fosphenytoin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.