Oxcarbazepine Tablets — Class III drug recall D-343-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2013-12-18, distributed nationwide. SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation reve
| Recall number | D-343-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-12-11 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 8,550 cartons |
| Reason classes | potency, specification failure |
| NDC | 00054-0097-20, 00054-0097-25 |
| Expiration dates | 2014-03-20 |
Product
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
Reason for recall
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight 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-343-2014. 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.