Tiglutik riluzole oral suspension recalled for failed viscosity specifications
ITF Pharma is recalling 1,792 bottles of Tiglutik (riluzole) oral suspension due to out-of-specification viscosity test results. The affected lots are 2231901 and 2307901, distributed to Tennessee.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medication where manufacturing defect (out-of-spec viscosity) poses a risk to proper drug delivery, but no illnesses or injuries have been reported. This fits the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tiglutik (riluzole) oral suspension is a prescription medication for ALS treatment, manufactured by ITF Pharma Inc. The recall involves 1,792 bottles in 600 mL packages (two 300 mL bottles per carton), NDC 70726-0303-1 and 70726-0303-2.
Two lot numbers are affected: Lot 2231901 (expiration 11/30/2025) and Lot 2307901 (expiration 03/31/2026). The recall was issued because test results showed the viscosity of the suspension did not meet specifications. Viscosity is critical to the proper flow and absorption of liquid medications.
The affected product was distributed to one distributor in Tennessee, which may have distributed the medication further to retail pharmacies and patients. No illnesses or injuries related to the out-of-specification viscosity have been reported.
Patients currently taking Tiglutik should check the lot number on their medication bottle. Those with bottles matching the recalled lot numbers should contact their pharmacy or healthcare provider.
The recalled product
- Product
- TIGLUTIK (RILUZOLE)
- Brand
- TIGLUTIK
- Manufacturer
- ITF PHARMA INC
- Hazard
- viscosity-defect
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- LOT# 2231901
- Exp. 11/30/2025
- 2307901
- Exp. 03/31/2026
Distribution
Distributed in 1 state:
- TN
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