Lacosamide Oral Solution Recalled Due to Leaking Container

The US Food and Drug Administration (FDA) has issued a Class II recall for Lacosamide Oral Solution, USP, 10 mg/mL (200 mL bottle) following reports of a leaking unit when stored horizontally, raising concerns about product integrity and proper dosing. The recall involves 20 648 bottles from Batch #TZ5589, with an expiration date of January 31, 2026. The affected product was manufactured by Apotex Inc. in Canada and distributed in the United States by Apotex Corp., based in Weston, Florida. The recall was voluntarily initiated on May 28, 2025, and applies to product distributed nationwide.

The FDA classified this as a Class II recall on June 3, 2025, which means that use of the product may cause temporary or medically reversible health consequences, with the probability of serious injury being low. Notification was issued through multiple channels, including email, fax, letters, and potentially direct outreach. While no press release has been issued, pharmacists are advised to inspect inventory for the affected batch and remove any defective units to prevent dosing inconsistencies or medication loss due to leakage.

Lacosamide is an antiepileptic drug (AED) indicated for the treatment of partial-onset seizures in patients aged 4 years and older. Oral solution formulations are especially important for pediatric and swallowing-impaired populations, making container integrity critical.