Apotex Corp. recalls Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T…

Recall date

May 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0457-2025

FDA classification

Class II

Brand / firm

Apotex Corp.

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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