Phenytoin recalls

The FDA has published 9 recalls involving Phenytoin since 2013. The latest was reported on 27 Dec 2023. Most were for potency & assay. Amneal Pharmaceuticals of New York 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 recalls9since 2013

Last 12 months0reported

Class I222% of total

Ongoing0latest 27 Dec 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 22%Class II 5 56%Class III 2 22%

Why phenytoin is recalled

Companies

Brands

By year

2023333%
2022222%
2020111%
2017111%
2013222%

All phenytoin recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Drug	CLASS I	Phenytoin Oral Suspension, USP, 100 mg recalled	The Harvard Drug Group	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
21 Jun 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	LA, OH, PA
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide
4 Mar 2020Drug	CLASS I	Phenytoin Oral Suspension USP, 125 mg/ potency recalledPhenytoin	Taro Pharmaceuticals U.S.A	Potency & Assay	Nationwide
8 Feb 2017Drug	CLASS II	Phenytoin Oral Suspension, USP 100 mg/ dose cups recalled by VistaPharm	VistaPharm	Sterility	Nationwide
18 Dec 2013Drug	CLASS II	Phenytoin Oral Suspension USP 125mg/, For Oral Administration Only recalled	VistaPharm	Potency & Assay	Nationwide
13 Nov 2013Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	7 states

Should you stop taking Phenytoin?

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.