May 2025 FDA Recall Drug by Apotex Corp.
D-0457-2025 - Defective Container

This Class II drug recall was voluntarily initiated by Apotex Corp. on May 28, 2025 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0457-2025

Reason for Recall
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Initiated
05-28-2025
Reported
06-11-2025
Quantity
20,648 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96953
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4

Batch or Lot Expiration Information

Batch# TZ5589, Exp Date: 01/31/2026