OXYCODONE HYDROCHLORIDE C II Oral Solution USP — Class III drug recall D-1486-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2014-08-06, distributed nationwide. Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
| Recall number | D-1486-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2014-07-28 |
| Classified | 2014-07-28 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 2,149 bottles |
| Reason classes | specification failure |
| NDC | 00054-0523-41 |
| Lot numbers | 360241A |
| Expiration dates | 2015-05 |
Product
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
Reason for recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
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-1486-2014. 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.