Mercaptopurine Tablets — Class III drug recall D-0367-2024
Terminated recall by Stason Pharmaceuticals, Inc., reported 2024-03-13, distributed nationwide. Failed Dissolution Specifications: results slightly under spec at at 9-months.
| Recall number | D-0367-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stason Pharmaceuticals, Inc., Irvine, CA, United States |
| Recall initiated | 2024-02-09 |
| Classified | 2024-03-06 |
| Reported by FDA | 2024-03-13 |
| Terminated | 2026-02-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 69076-0913-02, 69076-0913-25 |
| Expiration dates | 2024-04-30, 2024-07-31, 2024-10-31 |
Product
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Reason for recall
Failed Dissolution Specifications: results slightly under spec at at 9-months.
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-0367-2024. 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.