Nystatin (VistaPharm) – Impurity Specifications (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Brand
VistaPharm, Inc.
Lot Codes / Batch Numbers
Lots: a) 505300 Exp. Dec 2018, 522200 Exp. Apr 2019, 534400 Exp. Jul 2019, 539000 Exp. Aug 2019, 543400 Exp. Sep 2019, b) 523600, 522200X Exp. Apr 2019, 535500 Exp. Jul 2019, 540700 Exp. Aug 2019, 543300 Exp. Sep 2019, 550100 Exp. Oct 2019.
Products Sold
Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 2019; b) 523600, 522200X Exp. Apr 2019; 535500 Exp. Jul 2019; 540700 Exp. Aug 2019; 543300 Exp. Sep 2019; 550100 Exp. Oct 2019.
VistaPharm, Inc. is recalling NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cup due to Failed Impurities/Degradation Specifications:Out of specification for impurities.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026