Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nystatin Oral Suspension Recalled by VistaPharm, Inc. Due to CGMP Deviations: Purified water used to manufacture the...
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/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Quantity: 55,191 unit dose cups
Why Was This Recalled?
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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