Why it was recalled
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
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
Lot numbers, UPCs & expiration codes
Batch # TZ5589, Exp Date: 01/31/2026
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0457-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 28, 2025
- FDA report date
- Jun 11, 2025
- Quantity
- 20,648 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0457-2025, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 96953
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Batch # TZ5589, Exp Date: 01/31/2026
- Postal code
- 33326-3253
- Report date
- Jun 11, 2025
- Product type
- Drugs
- Recall number
- D-0457-2025
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 20,648 bottles
- Reason for recall
- Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 28, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 3, 2025