Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.