Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zileuton Extended-Release Tablets Recalled by Chiesi USA, Inc. Due to Failed Dissolution Specifications: Out of specification result for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Chiesi USA, Inc. directly.
Affected Products
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Quantity: 2598 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out of specification result for dissolution.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Chiesi USA, Inc.
Chiesi USA, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report