Lacosamide Oral Solution recall
FDA recall D-0457-2025 · initiated May 28, 2025
Apotex Corp. recalled Lacosamide Oral Solution in May 2025 — an FDA Class II recall (D-0457-2025) because Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 20,648 bottles
Details
- 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
- Recalling company
- Apotex
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 28, 2025
- FDA report date
- Jun 11, 2025
Frequently asked
- Was Lacosamide Oral Solution recalled?
- Apotex Corp. recalled Lacosamide Oral Solution in May 2025 — an FDA Class II recall (D-0457-2025) because Defective Container: This recall is being initiated due to a leaking unit stored horizontally. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lacosamide Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0457-2025 was: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- Is a recalled Lacosamide Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lacosamide Oral Solution are affected?
- Distributed: US Nationwide.. The recall covers these lots — Batch # TZ5589, Exp Date: 01/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0457-2025.