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

Recall Number: D-0457-2025

Firm: Apotex Corp.

Classification: Class II

Status: Ongoing

Report Date: 20250611

Initiation Date: 20250528

Termination Date:

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

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