Drug recall D-0457-2025

Class II Ongoing reported Jun 11, 2025

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
20,648 bottles
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
May 28, 2025