Class III — Low Risk

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...

Date: June 23, 2020
Company: VistaPharm, Inc.
Status: Terminated
Source: FDA (Drug)

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.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report