Class II · Moderate risk
Riluzole
Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.
Tiglutik (riluzole)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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)
Affected NDCs
70726-0303-01
70726-0303-02
Compare with the code on your package — it is the most precise check available.
Drug: Riluzole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tiglutik Riluzole NDC 70726-0303 |
50 mg/10mL | Liquid Oral |
Edw Pharma, INC | Rx |
- Recalling firm
- Itf Pharma INC
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0115-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Riluzole recalls
See all
Class II · Moderate risk
RILUZOLE Tablet
Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.
Other failed specification recalls from 2023
All failed specification recalls
Class III · Low risk
Anoro Ellipta
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class II · Moderate risk
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class II · Moderate risk
Ondansetron Injection
Failed pH Specifications
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