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 products; 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 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
Quantity: 380,700 cups
Why Was This Recalled?
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Where Was This Sold?
United States including Puerto Rico
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