Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xactdose Phenytoin Oral Suspension Recalled by VistaPharm, Inc. Due to Defective container; lidding deformity allows the contained product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact VistaPharm, Inc. directly.
Affected Products
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Quantity: 27,221 unit dose cups
Why Was This Recalled?
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About VistaPharm, Inc.
VistaPharm, Inc. has 32 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report