Boehringer Ingelheim Roxane Oxcarbazepine Oral Suspension Recall

Why it was recalled

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Product description

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

Lot numbers, UPCs & expiration codes

Lot # 161304B, Exp. OCT 2013

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-002-2014
Classification: Class II
Status: Terminated
Recall initiated: Apr 3, 2013
FDA report date: Nov 27, 2013
Quantity: 10,267 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Boehringer Ingelheim Roxane Inc

Original FDA data

Every field from FDA enforcement report D-002-2014, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 66289
Address: 1809 Wilson Rd
Code information: Lot # 161304B, Exp. OCT 2013
Postal code: 43228-9579
Report date: Nov 27, 2013
Product type: Drugs
Recall number: D-002-2014
Classification: Class II
Recalling firm: Boehringer Ingelheim Roxane Inc
Product quantity: 10,267 bottles
Termination date: Feb 11, 2014
Reason for recall: Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
Distribution pattern: Nationwide
Recall initiation date: Apr 3, 2013
Initial firm notification: Letter
Center classification date: Nov 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-002-2014, published Nov 27, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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