ITF PHARMA INC recalls Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for
ITF Pharma recalls Tiglutik oral suspension (50 mg/10 mL) due to failed viscosity tests. This medication is prescription-only and may not mix properly, affecting dosing accuracy.
Lower-risk recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Contact the company & request your remedy
What happened, in plain English
ITF Pharma is recalling Tiglutik oral suspension because it failed viscosity tests. This means the suspension might not mix properly, leading to incorrect dosing for patients using it as prescribed. Read more at govinfonow.com/recall/33040-itf-pharma-recalls-tiglutik-oral-suspension-due-to-viscosity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/33040-itf-pharma-recalls-tiglutik-oral-suspension-due-to-viscosity-issues · Updated September 23, 2026 · FDA enforcement record: FDA #D-0115-2024
Cite this page
“ITF Pharma Recalls Tiglutik Oral Suspension Due to Viscosity Issues.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33040-itf-pharma-recalls-tiglutik-oral-suspension-due-to-viscosity-issues. Based on FDA recall #D-0115-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2024%22&limit=1).
Why it’s dangerous
The suspension failed viscosity tests, meaning it may not mix properly. This could lead to incorrect dosing if the medication is not properly mixed before use, potentially affecting treatment effectiveness.
Who’s affected
Prescription patients using Tiglutik oral suspension (50 mg/10 mL) manufactured by ITF Pharma. Those with specific lot numbers are most at risk.
How to tell if you have this one
Check for the product name 'Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each)'. Look for lot numbers 2231901 (expiring 11/30/2025) or 2307901 (expiring 03/31/2026).
- Brand
ITF Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging to confirm if your product is affected.
Questions people ask
Is this medication safe to use?
The recall is due to failed viscosity tests, which may affect dosing accuracy. It is not safe to use as intended without checking the recall status.
What should I do if I have this medication?
Check the lot number on the packaging. If it matches 2231901 (expiring 11/30/2025) or 2307901 (expiring 03/31/2026), contact ITF Pharma for instructions.
Is there a risk of serious injury?
The hazard is related to potential dosing errors, not direct injury. The risk level is low as the issue affects medication accuracy, not immediate safety.
Contact ITF Pharma
We’ve drafted a message you can send ITF Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0115-2024 — ITF Pharma ITF Pharma Hello, I own a ITF Pharma that is covered by recall D-0115-2024 from ITF Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0115-2024 (October 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0115-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.