Medications & Supplements/Prescription Drugs

Tiglutik (riluzole) Oral Suspension Recalled for Failing Viscosity Tests

Agency Publication Date: November 21, 2023

Summary

ITF Pharma Inc. is recalling 1,792 bottles of Tiglutik (riluzole) Oral Suspension (50 mg/10 mL). This prescription medication is being recalled because it failed viscosity tests, meaning the thickness of the liquid did not meet quality standards. No incidents or injuries have been reported to date regarding this issue.

Risk

If the suspension liquid is too thick or too thin, it may lead to improper dosing or difficulty for patients to swallow or administer the drug. This is a quality-related defect that could affect the consistency of the medication.

What You Should Do

This recall affects Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL) sold in 600 mL cartons containing two 300 mL bottles. Check your product for lot numbers 2231901 (Exp. 11/30/2025) or 2307901 (Exp. 03/31/2026).
Look for identification numbers NDC 70726-0303-1 on the outer carton and NDC 70726-0303-2 on the individual bottles to confirm if your medication is part of this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL

Variants: 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only

Lot Numbers:

2231901 (Exp. 11/30/2025)

2307901 (Exp. 03/31/2026)

NDC:

70726-0303-1

70726-0303-2

Recall #: D-0115-2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93278

Status: Resolved

Manufacturer: ITF PHARMA INC

Sold By: Distributors; Pharmacies

Manufactured In: United States

Units Affected: 1,792 bottles

Distributed To: Tennessee

Agency Last Updated: December 1, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL) sold in 600 mL cartons containing two 300 mL bottles. Check your product for lot numbers 2231901 (Exp. 11/30/2025) or 2307901 (Exp. 03/31/2026).

Look for identification numbers NDC 70726-0303-1 on the outer carton and NDC 70726-0303-2 on the individual bottles to confirm if your medication is part of this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.