CLASS II Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report
Oxcarbazepine Oral Suspension, 300 mg recalled
Boehringer Ingelheim Roxane is recalling Oxcarbazepine Oral Suspension, 300 mg, distributed nationwide in the US. The recall was initiated on 3 Apr 2013 and the FDA has classified it as Class II.
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-002-2014
- FDA event ID
- 66289
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 3 Apr 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +231 days |
| 27 Nov 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
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Product as listed by the FDA
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Which lots are affected?
Lot # 161304B, Exp. OCT 2013
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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|---|---|---|---|---|---|
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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 |