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)

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ITF PHARMA INC
Reason for Recall:
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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)

Product Codes/Lot Numbers:

LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026

Distribution:

Distributed in: TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0115-2024