The Recall Desk
LowFDA (Drugs)·D-1377-2020·Announced 2020-07-15

VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

What this means for you

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

Our severity reasoning: The FDA classifies this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.

Plain-English summary

VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 500,000 units/5mL Cup, which delivers 5 mL. The product is prescription-only and was manufactured in Largo, FL. The recall affects 380,700 cups distributed in the United States, including Puerto Rico.

The recall was initiated due to failed impurities and degradation products. Specifically, the source text notes the presence of an impurity peak that exceeds the approved specification. The affected lots are 619800 (Exp. 12/31/2020), 626200 (Exp. 01/31/2021), 619800X (Exp. 12/31/2020), and 626200X (Exp. 01/31/2021).

The U.S. Food and Drug Administration classifies this as a Class III recall. Consumers and healthcare providers should check their inventory for the specific NDCs 66689-037-50, 66689-037-01, and 66689-037-99 and the lot numbers listed above.

The recalled product

Product
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.
Manufacturer
VistaPharm, Inc.
Category
Drug — Antifungal
Hazard
Affected units
380,700

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 (7)

  • Lot #: a) 619800
  • Exp. 12/31/2020
  • 626200
  • Exp. 01/31/2021
  • b) 619800X
  • 626200X
  • Exp. 01/31/2021.

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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