Reported Nov 29, 2023 · Terminated

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for…

Itf Pharma Inc.

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: ITF PHARMA INC · 850 Cassatt Rd · Berwyn, PA · 19312-2701

Is this the product you have?

  • Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn
  • PA 19312 USA NDC70726-0303-1 (carton) and 70726-0303-2 (bottle)
Lot codes and dates
    • LOT# 2231901
    • Exp. 11/30/2025
    • 2307901
    • Exp. 03/31/2026
Amount recalled
1,792 bottles

Where it was sold

Why it was recalled

Failed Viscosity Specifications: Out-of-specification test results for viscosity

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

Notice updated Jan 28, 2025 · Data as of Sep 19, 5:07 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.