Class III · Low risk
Mercaptopurine Tablets
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Is Mercaptopurine recalled?
Not under an active recall.
Mercaptopurine was recalled 6 times in the past — all now closed. Most recent: Feb 9, 2024.
Most common reason: Dissolution failure (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mercaptopurine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mercaptopurine recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
Mercaptopurine Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class III · Low risk
Mercaptopurine Tablets USP
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
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