CLASS II Drug recall · Reported 25 Sep 2019 · FDA Enforcement Report
Oxcarbazepine Oral Suspension, USP, 300 mg recalled
West-Ward Columbus is recalling Oxcarbazepine Oral Suspension, USP, 300 mg/ per, distributed nationwide in the US. The recall was initiated on 9 Sep 2019 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-1863-2019
- FDA event ID
- 83698
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Sep 2019
- FDA classified
- 16 Sep 2019
- Reported
- 25 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 9 Sep 2019 | Recall initiated by company | |
| 16 Sep 2019 | Classified by FDA | +7 days |
| 25 Sep 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specificattion
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 Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specificattion
Which lots are affected?
Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
Where was it sold?
Nationwide USA 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 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.
More recalls from West-Ward Columbus
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward ColumbusLeucovorin Calcium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS III | Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus | West-Ward Columbus | 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 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 |
| Drug | CLASS II | OXcarbazepine Tablet, 600 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |