Tiglutik recall
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…
Why was Tiglutik recalled?
Failed Viscosity Specifications: Out-of-specification test results for viscosity
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
- 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…
- Recalling firm
- ITF PHARMA INC
- Quantity
- 1,792 bottles
- Distribution
- Distributed to one distributor in TN who may have further distributed.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)