Medications & Supplements/Prescription Drugs

Lacosamide Oral Solution Recalled Due to Defective Leaking Containers

Agency Publication Date: June 3, 2025

Summary

Apotex Corp. is recalling 20,648 bottles of Lacosamide (lacosamide) Oral Solution, USP (10 mg/mL, 200 mL) because the containers may leak when stored horizontally. The recall affects bottles from Batch TZ5589 with an expiration date of January 31, 2026. This prescription medication is used to treat seizures, and a leaking container could result in an incorrect dose or contamination of the medicine.

Risk

A leaking bottle can cause a patient to receive less than the prescribed dose of medication, which can lead to uncontrolled seizures. Additionally, a compromised seal may allow environmental contaminants to enter the container.

What You Should Do

This recall affects Lacosamide Oral Solution, USP (10 mg/mL, 200 mL) with NDC 60505-0405-4, specifically Batch TZ5589 and an expiration date of 01/31/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Apotex Corp. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lacosamide Oral Solution, USP (200 mL)

Variants: 10 mg/mL, Rx Only

Lot Numbers:

TZ5589 (Exp 01/31/2026)

NDC:

60505-0405-4

Recall #: D-0457-2025; Quantity: 20,648 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96953

Status: Active

Manufacturer: Apotex Corp.

Sold By: Pharmacies

Manufactured In: Canada

Units Affected: 20,648 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.