Mercaptopurine Tablets — Class II drug recall D-0300-2015
Terminated recall by American Health Packaging, reported 2014-12-24, distributed nationwide. Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recal
| Recall number | D-0300-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2014-11-19 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,496 cartons |
| Reason classes | specification failure |
| NDC | 68084-0325-21 |
| Lot numbers | 134770, 140862, 141596, 142450 |
| Expiration dates | 2015-01, 2015-02, 2015-03, 2015-05 |
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
Reason for recall
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.
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-0300-2015. 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.