Oxcarbazepine Oral Suspension — Class II drug recall D-002-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2013-11-27, distributed nationwide. Resuspension Problems: Recalled lot did not meet resuspendability requirements.
| Recall number | D-002-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2013-04-03 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 10,267 bottles |
| NDC | 00054-0199-59 |
| Lot numbers | 161304B |
| Expiration dates | 2013-10-20 |
Product
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
Reason for recall
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
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-002-2014. 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.