Mercaptopurine Tablets — Class II drug recall D-0249-2015
Terminated recall by Prometheus Laboratories Inc., reported 2014-11-26, distributed nationwide. Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
| Recall number | D-0249-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prometheus Laboratories Inc., San Diego, CA, United States |
| Recall initiated | 2014-10-22 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2016-02-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 49884-0922-02, 49884-0922-04 |
| Expiration dates | 2015-06-20, 2015-10-20, 2016-02-20 |
Product
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
Reason for recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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-0249-2015. 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.