Recalls / Class II
Class IID-0457-2025
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
- Affected lot / code info
- Batch # TZ5589, Exp Date: 01/31/2026
Why it was recalled
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 20,648 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-05-28
- FDA classified
- 2025-06-03
- Posted by FDA
- 2025-06-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0457-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.