Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL) Recalled by ITF PHARMA INC Due to Failed Viscosity Specifications: Out-of-specification test results for viscosity

Date: October 20, 2023
Company: ITF PHARMA INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ITF PHARMA INC directly.

Affected Products

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 NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)

Quantity: 1,792 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: TN

Affected (1 state)Not affected

About ITF PHARMA INC

ITF PHARMA INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report