Lacosamide Oral Solution 10 mg/mL Recall
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Lacosamide Oral Solution 10 mg/mL recalled?
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Batch # TZ5589, Exp Date: 01/31/2026
- Agency record number
- D-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…
- Recalling firm
- Apotex Corp.
- Quantity
- 20,648 bottles
- Distribution
- US Nationwide.
- Recall started
- May 28, 2025
- Report date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)