Medications & Supplements/Prescription Drugs

Akorn, Inc.: Levetiracetam Oral Solution Recalled Due to Leaking Bottles

Agency Publication Date: January 11, 2021

Summary

Akorn, Inc. is recalling approximately 22,248 bottles of Levetiracetam Oral Solution (100 mg/mL) after receiving multiple customer complaints regarding bottles leaking. This recall affects 16 fl oz (473 mL) bottles of the prescription medication used to treat seizures. Leaking containers can lead to loss of product, potential contamination, and inaccurate dosing if the medication is not properly contained.

Risk

Defective containers that leak can compromise the sterility or integrity of the liquid medication. Additionally, if the solution leaks, patients may receive an incorrect dose or find the medication is unavailable when needed to manage seizure activity.

What You Should Do

Check your medication bottles to see if they are Levetiracetam Oral Solution (100 mg/mL) in 16 fl oz (473 mL) bottles labeled with NDC 50383-241-16.
Identify if your product is from an affected lot by looking for Lot #: 373859, 373863, or 373865 with an expiration date of 05/2022, or Lot #: 374586 with an expiration date of 06/2022.
Contact your healthcare provider or pharmacist immediately for guidance if you find your bottle is leaking or if you have an affected lot number.
Return any unused or leaking product to your pharmacy for a refund and to obtain a replacement supply.
Contact Akorn, Inc. at the contact information provided on your prescription bottle or through your pharmacist for further instructions regarding this recall.
For additional questions, 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

Pharmacy refund and consultation

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, 100 mg/mL (16 fl oz / 473 mL)

Model:

NDC 50383-241-16

Recall #: D-0221-2021

Lot Numbers:

373859 (Exp 05/2022)

373863 (Exp 05/2022)

373865 (Exp 05/2022)

374586 (Exp 06/2022)

Date Ranges: 05/2022, 06/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87051

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 22,248 bottles

Distributed To: Nationwide

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 medication bottles to see if they are Levetiracetam Oral Solution (100 mg/mL) in 16 fl oz (473 mL) bottles labeled with NDC 50383-241-16.

Identify if your product is from an affected lot by looking for Lot #: 373859, 373863, or 373865 with an expiration date of 05/2022, or Lot #: 374586 with an expiration date of 06/2022.

Contact your healthcare provider or pharmacist immediately for guidance if you find your bottle is leaking or if you have an affected lot number.

Return any unused or leaking product to your pharmacy for a refund and to obtain a replacement supply.

Contact Akorn, Inc. at the contact information provided on your prescription bottle or through your pharmacist for further instructions regarding this recall.

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