OXYCODONE and ACETAMINOPHEN — Class II drug recall D-1572-2014
Terminated recall by Qualitest Pharmaceuticals, reported 2014-09-10, distributed nationwide. Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
| Recall number | D-1572-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2014-08-27 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2016-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 23,544 bottles |
| NDC | 00603-4982-21 |
Product
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Reason for recall
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
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-1572-2014. 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.