Class II · Moderate risk
Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Lacosamide Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
60505-0405-04
Compare with the code on your package — it is the most precise check available.
Drug: Lacosamide
- Recalling firm
- Apotex Corp.
- NDC code
- 60505-0405-4
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0457-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Lacosamide recalls
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Class II · Moderate risk
Lacosamide Tablets 150mg
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 200mg
CGMP Deviations
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Class II · Moderate risk
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