CLASS III Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report
Oxcarbazepine Tablets, 150 mg recalled by Boehringer Ingelheim Roxane
Boehringer Ingelheim Roxane is recalling Oxcarbazepine Tablets, 150 mg, distributed nationwide in the US. The recall was initiated on 18 Mar 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-343-2014
- FDA event ID
- 66288
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Mar 2013
- FDA classified
- 11 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 18 Mar 2013 | Recall initiated by company | |
| 11 Dec 2013 | Classified by FDA | +268 days |
| 18 Dec 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Which lots are affected?
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Roxane
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
Other Oxcarbazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets 600mg recalled by Sun Pharmaceutical IndustriesOxcarbazepine | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS I | Oxcarbazepine Tablets, 300 mg per carton (10 recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets, 300 mg recalled by Caraco PharmaceuticalOxcarbazepine | Caraco Pharmaceutical Laboratories | Packaging Defects | Nationwide |