D-0457-2025 Class II Ongoing
FDA drug recall D-0457-2025 was initiated by Apotex Corp. on May 28, 2025 and is designated Class II. Reason for recall: Defective Container: This recall is being initiated due to a leaking unit stored horizontally. The recall status is ongoing. Affected quantity: 20,648 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 11, 2025
- Initiation Date
- May 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,648 bottles
Product description
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.
Distribution pattern
US Nationwide.
Code information
Batch # TZ5589, Exp Date: 01/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0457-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026