ALLOPURINOL TABLETS — Class III drug recall D-1405-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-09-09, distributed nationwide. Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
| Recall number | D-1405-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-07-20 |
| Classified | 2015-09-01 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-03-07 |
| Distributed | Nationwide (US) |
| Quantity | 21,552 units |
| NDC | 00603-2115, 00603-2115-02, 00603-2115-04, 00603-2115-21, 00603-2115-28, 00603-2115-32, 00603-2115-93, 00603-2116, 00603-2116-02, 00603-2116-21, 00603-2116-28, 00603-2116-32 |
Product
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
Reason for recall
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
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-1405-2015. 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.