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 Lupin Pharmaceuticals Inc. Due to Failed Dissolution Specifications: Out of specification test results...
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Quantity: 3,216 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report