---
title: "Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle... — FDA record D-0115-2024 | Is It on Recall"
description: "Failed Viscosity Specifications: Out-of-specification test results for viscosity"
url: https://isitonrecall.com/recall/fda-drug-d-0115-2024-tiglutik-riluzole-oral-suspension-50-mg-10-ml-5-mg-ml-600-ml-two-bottles-300-ml-each-rx-only-manufac/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured fo... — FDA record D-0115-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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)
- **Reason**: Failed Viscosity Specifications: Out-of-specification test results for viscosity
- **Classification**: Class II
- **Recalling firm**: ITF PHARMA INC
- **Quantity**: 1,792 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0115-2024

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0115-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distributed to one distributor in TN who may have further distributed.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Tennessee](https://isitonrecall.com/state/tennessee/)

## Dates in the source

- **Report date**: Nov 29, 2023
- **Recall initiation date**: Oct 20, 2023
- **Center classification date**: Nov 21, 2023
- **Termination date**: Jan 28, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0115-2024%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [ITF PHARMA INC records](https://isitonrecall.com/brand/itf-pharma-inc/)