The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1378-2020·Announced 2020-07-15

VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

VistaPharm, Inc. is recalling 14,760 bottles of Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL). The product is identified by Lot # 639000 and has an expiration date of 10/31/2021. The recall is due to the presence of an impurity peak that exceeds the approved specification.

The affected product was distributed in the United States, including Puerto Rico. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The product is prescription-only (Rx Only).

The recalled product

Product
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Manufacturer
VistaPharm, Inc.
Category
Drug — Antifungal
Hazard
Affected units
14,760

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 639000
  • Exp. 10/31/2021

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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