CLASS II ONGOING Drug recall · Reported 11 Jun 2025 · FDA Enforcement Report
Lacosamide Oral Solution, USP, 10 mg/mL recalled by Apotex
Apotex is recalling Lacosamide Oral Solution, USP, 10 mg/mL, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0457-2025
- FDA event ID
- 96953
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 3 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 28 May 2025 | Recall initiated by company | |
| 3 Jun 2025 | Classified by FDA | +6 days |
| 11 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Which lots are affected?
Batch # TZ5589, Exp Date: 01/31/2026
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apotex
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
Other Lacosamide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lacosamide Tablets, USP, C V, 100mg recalled by Annora Pharma PrivateLacosamide | Annora Pharma Private | Packaging Defects | Nationwide |
| Drug | CLASS II | Lacosamide Tablets, 50mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lacosamide Tablets 200mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lacosamide Tablets, 100mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lacosamide Tablets 150mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |