Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Nystatin Oral Suspension Recalled by VistaPharm, Inc. Due to Failed Impurities/Degradation Specifications: Presence of an impurity peak...
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
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Quantity: 2,208,500 cups/18696 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
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