Recall
FDAHealthMay 28, 2025

Apotex Corp. — 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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 28, 2025

US Nationwide.

What's affected?

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

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20,648 bottles.

View original FDA notice →

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