Mercaptopurine Tablets — Class II drug recall D-1659-2012
Terminated recall by Prometheus Laboratories Inc., reported 2012-08-29, distributed nationwide. Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
| Recall number | D-1659-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prometheus Laboratories Inc., San Diego, CA, United States |
| Recall initiated | 2012-06-29 |
| Classified | 2012-08-22 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-03-27 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 49884-0922-02, 49884-0922-04 |
Product
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.
Reason for recall
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1659-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.