Tiglutik — Class II drug recall D-0115-2024
Terminated recall by ITF PHARMA INC, reported 2023-11-29, distributed in TN. Failed Viscosity Specifications: Out-of-specification test results for viscosity
| Recall number | D-0115-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ITF PHARMA INC, Berwyn, PA, United States |
| Recall initiated | 2023-10-20 |
| Classified | 2023-11-21 |
| Reported by FDA | 2023-11-29 |
| Terminated | 2025-01-28 |
| Distributed | TN |
| Quantity | 1,792 bottles |
| NDC | 70726-0303, 70726-0303-01, 70726-0303-02 |
| Lot numbers | 2231901, 2307901 |
| Expiration dates | 2025-11-30, 2026-03-31 |
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 for recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0115-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.