Class II โ€” Potential Health Hazard

Potential health hazard โ€” 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 USP Dissolution Test Requirements: The recalled lots...

Date: June 29, 2012
Company: Prometheus Laboratories Inc.
Status: Terminated
Source: FDA (Drug)

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, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

Quantity: a) 25,516 bottles; b) 2,569 bottles

Why Was This Recalled?

Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Prometheus Laboratories Inc.

Prometheus Laboratories Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report