FDA Recall D-0457-2025
Apotex Corp. · Weston, FL
Class II Ongoing 351 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0457-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- US Nationwide.
- Recall initiated
- 2025-05-28
- Classified by FDA Center
- 2025-06-03
- FDA published
- 2025-06-11
- Recalling firm
- Apotex Corp.
- Firm location
- Weston, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.