Ethosuximide recalls

The FDA has published 4 recalls involving Ethosuximide since 2018. The latest was reported on 18 Aug 2021. Pfizer 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 recalls4since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Aug 2021

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 2 50%Class III 2 50%

Why ethosuximide is recalled

Companies

Brands

Ethosuximide125%
Zarontin125%

By year

2021125%
2019250%
2018125%

All ethosuximide recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
18 Aug 2021Drug	CLASS II	Ethosuximide Oral Solution USP 250 mg recalled by PAI HoldingsEthosuximide	PAI Holdings	Manufacturing (CGMP) Deviations	Nationwide
2 Oct 2019Drug	CLASS III	ethosuximide capsules, USP, 250 mg recalled by Pfizer	Pfizer	Other	Nationwide
2 Oct 2019Drug	CLASS III	Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl recalled by PfizerZarontin	Pfizer	Other	Nationwide
12 Sep 2018Drug	CLASS II	Ethosuximide Capsules, USP, 250 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

Should you stop taking Ethosuximide?

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.