FDA Drug recall D-0115-2024
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., Be…
- FDA Drug
- Class II
- terminated
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of 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., Be… by Itf Pharma, citing failed Viscosity Specifications: Out-of-specification test results for viscosity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0115-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-20 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Itf Pharma |
| Distribution | TN |
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
Identifiers
| ndc | 70726-0303-2 |
|---|---|
| ndc | 70726-0303-1 |
| code_info | LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.