Medications & Supplements/Prescription Drugs

Ucb, Inc: Keppra (levetiracetam) Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: July 25, 2019

Summary

Ucb, Inc. is recalling 2,088 bottles of Keppra (levetiracetam) 1000 mg tablets because the medication failed to meet dissolution specifications during testing. This means the tablets may not dissolve at the correct rate in the body, potentially affecting how the medication is absorbed and its effectiveness in managing seizures. This recall affects 60-count bottles of Rx-only Keppra distributed in Tennessee.

Risk

If the medication fails to dissolve properly, the patient may not receive the intended dose of the active ingredient, levetiracetam, at the necessary time. For patients taking this medication to control seizures, a reduction in drug effectiveness could lead to breakthrough seizures or a loss of seizure control.

What You Should Do

Check your medication bottle for the product name Keppra (levetiracetam) 1000 mg tablets and the NDC number 50474-597-66.
Verify if your bottle is part of the affected lot by looking for Lot number 908946 with an Expiration Date of 02/2022.
If you identify that your medication is part of the recalled lot, do not stop taking the medication without first consulting your doctor, as suddenly stopping seizure medication can be dangerous.
Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to discuss any concerns regarding your treatment.
Return any unused portions of the affected medication to your pharmacy for a refund and contact Ucb, Inc. at their Smyrna, Georgia office for further instructions.
For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Keppra (levetiracetam) 1000 mg tablets (60-count bottle)

Model:

NDC 50474-597-66

Lot Numbers:

908946 (Exp. 02/2022)

Date Ranges: Expiration 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83368

Status: Resolved

Manufacturer: Ucb, Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 2088 bottles

Distributed To: Tennessee

Agency Last Updated: August 21, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication bottle for the product name Keppra (levetiracetam) 1000 mg tablets and the NDC number 50474-597-66.

Verify if your bottle is part of the affected lot by looking for Lot number 908946 with an Expiration Date of 02/2022.

If you identify that your medication is part of the recalled lot, do not stop taking the medication without first consulting your doctor, as suddenly stopping seizure medication can be dangerous.

Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to discuss any concerns regarding your treatment.

Return any unused portions of the affected medication to your pharmacy for a refund and contact Ucb, Inc. at their Smyrna, Georgia office for further instructions.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.