Medications & Supplements/Prescription Drugs

Lannett Company, Inc.: Levetiracetam Oral Solution Recalled for Microbial Contamination

Agency Publication Date: December 13, 2019

Summary

Lannett Company, Inc. is recalling approximately 16,668 bottles of Levetiracetam (100mg/mL) Oral Solution, an Rx-only medication used to treat seizures. The recall was initiated because laboratory testing found out-of-specification results for the Total Aerobic Microbial Count, meaning the product contains more bacteria than is safe. Consumers should be aware that these affected bottles were distributed nationwide within the United States.

Risk

The product may contain microbial contamination which can pose a significant health risk, particularly to individuals with compromised immune systems who may develop infections from the contaminated medication.

What You Should Do

Check your medicine cabinet for 473 mL (16 fl. oz.) bottles of Levetiracetam Oral Solution 100mg/mL with NDC 54838-0548-80.
Verify the lot numbers and expiration dates: Look for lot numbers 2190A or 2191A with an expiration date of 07/2021.
Immediately contact your healthcare provider or pharmacist for guidance regarding your seizure medication and to arrange for a safe alternative.
Return any unused product from the affected lots to your pharmacy for a refund.
Contact Lannett Company, Inc. at their Philadelphia headquarters for further instructions on the recall process.
For additional questions or to report adverse reactions, 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 provider 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: Levetiracetam Oral Solution 100mg/mL (473 mL / 16 fl. oz.)

Model:

NDC 54838-0548-80

Lot Numbers:

2190A (Exp. 07/2021)

2191A (Exp. 07/2021)

Date Ranges: 07/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84427

Status: Resolved

Manufacturer: Lannett Company, Inc.

Manufactured In: United States

Units Affected: 16,668 bottles

Distributed To: Nationwide

Agency Last Updated: December 27, 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

What You Should Do

Check your medicine cabinet for 473 mL (16 fl. oz.) bottles of Levetiracetam Oral Solution 100mg/mL with NDC 54838-0548-80.

Verify the lot numbers and expiration dates: Look for lot numbers 2190A or 2191A with an expiration date of 07/2021.

Immediately contact your healthcare provider or pharmacist for guidance regarding your seizure medication and to arrange for a safe alternative.

Return any unused product from the affected lots to your pharmacy for a refund.

Contact Lannett Company, Inc. at their Philadelphia headquarters for further instructions on the recall process.

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