Nystatin Oral Suspension (VistaPharm) – Impurity Specification Failure (2017)
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, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Brand
VistaPharm, Inc.
Lot Codes / Batch Numbers
a) Lot #: 431300, Exp. 01/2018, b) Lot #: 434000, 432500, Exp. 07/2017, 462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017, 460500, 461500, Exp. 01/2018.
Products Sold
a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-0 due to Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.. 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: Presence of an impurity peak that exceeds approved specification.
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