FDA Drugs recall ·
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only… recall
- Recall number
- D-0457-2025
- Date
- (initiated May 28, 2025)
- Company / brand
- Apotex Corp.
2400 N Commerce Pkwy Ste 400, Weston, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20,648 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # TZ5589, Exp Date: 01/31/2026
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0457-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.