FDA Drug · D-0457-2025

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisBatch # TZ5589, Exp Date: 01/31/2026

Recalling firm: Apotex Corp., Weston, FL
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 20,648 bottles
Distribution: US Nationwide.
Recall initiated: May 28, 2025
Classified: June 3, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0457-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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