Reported Jun 11, 2025 · Ongoing

Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L…

Apotex Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253

Is this the product you have?

  • Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only
  • Manufactured byApotex Inc., Toronto, Ontario, Canada M9L 1T9
  • Manufactured for
    • Apotex Corp
    • Weston FL 33326
    • NDC 60505-0405-4
Lot codes and dates
  • Batch # TZ5589
  • Exp Date01/31/2026
Amount recalled
20,648 bottles

Where it was sold

  • Nationwide

Why it was recalled

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 3:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.