Riluzole Oral Suspension (Tiglutik) Shortage: Manufacturing Issues Impact Availability
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The FDA reports a shortage of Riluzole Oral Suspension (Tiglutik) due to manufacturing interruptions, though some Teglutik presentations remain available.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Riluzole) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What's in Shortage
Riluzole Oral Suspension, a medication categorized for use in neurology, is currently listed in the FDA drug shortage database. This shortage affects specific presentations of the brand-name medications TEGLUTIK and TIGLUTIK. While some concentrations remain available, the 50 mg/10 mL presentation of Tiglutik is currently unavailable.
Which Manufacturers Are Affected
EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)
The following presentations are currently Available:
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0304-1)
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0305-1)
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0306-1)
The following presentation is currently Unavailable:
- Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-2)
Patients or providers with questions can contact the manufacturer directly at 610-937-6172.
Why There's a Shortage
According to the manufacturer, the shortage of the Tiglutik 50 mg/10 mL presentation is due to a product manufacturing interruption related to viscosity testing. A date for the next product release is not available at this time.
What Patients Should Do
If you are currently prescribed Riluzole Oral Suspension, please consider the following steps:
- Consult your healthcare provider: Discuss the current availability and how it may impact your specific treatment plan.
- Speak with your pharmacist: Inquire about the stock status of the available 5 mg/1 mL presentations.
- Contact the manufacturer: You may call EDW Pharma, Inc. at 610-937-6172 for updates regarding supply timelines.
Disclaimer: Patients should always consult their healthcare provider or pharmacist regarding medication changes or treatment concerns.
Source
Information provided by the FDA Drug Shortage Database.
Initial Posting Date: 01/26/2024
Last Updated: 02/02/2026
Original source: FDA Official Notice ↗
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