Class III โ€” Low Risk

Low risk โ€” 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 Impurties/Degradation Specifications: out of specification results for...

Date: September 25, 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 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

Quantity: 14,244 16 oz bottles

Why Was This Recalled?

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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