Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Is Zileuton recalled?
Not under an active recall.
Zileuton was recalled 3 times in the past — all now closed. Most recent: Jun 10, 2022.
Most common reason: Dissolution failure (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zileuton. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Zileuton recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
ZYFLO CR (zileuton)
Failed Dissolution Specifications: Out of specification result for dissolution.
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