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:Out of specification for impurities.
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 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Quantity: 4,065,550 5 ml cups
Why Was This Recalled?
Failed Impurities/Degradation Specifications:Out of specification for impurities.
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