Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mercaptopurine Tablets Recalled by Prometheus Laboratories Inc. Due to Failed Dissolution Specifications: Product found to be out...
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 Prometheus Laboratories Inc. directly.
Affected Products
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Quantity: 16,296 bottles (60-count), 5,166 bottles (250-count)
Why Was This Recalled?
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Prometheus Laboratories Inc.
Prometheus Laboratories 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