Zileuton recalls

The FDA has published 2 recalls involving Zileuton since 2019. The latest was reported on 22 Jun 2022. Most were for potency & assay. Lupin Pharmaceuticals 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 recalls2since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 22 Jun 2022

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 2 100%Class III 0 0%

Why zileuton is recalled

Potency & Assay2100%

Companies

Lupin Pharmaceuticals150%
Chiesi USA150%

By year

2022150%
2019150%

All zileuton recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
22 Jun 2022Drug	CLASS II	Zileuton Extended-Release Tablets, 600 mg recalled	Lupin Pharmaceuticals	Potency & Assay	Nationwide
19 Jun 2019Drug	CLASS II	Zileuton Extended-Release Tablets, 600 mg recalled by Chiesi USA	Chiesi USA	Potency & Assay	Nationwide

Should you stop taking Zileuton?

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.