Medications & Supplements/Prescription Drugs

VistaPharm, Inc.: Nystatin Oral Suspension Recalled for Impurity Specification Failure

Agency Publication Date: July 8, 2020

Summary

VistaPharm, Inc. has voluntarily recalled 395,460 units of Nystatin Oral Suspension, an antifungal medication used to treat fungal infections in the mouth. This recall includes both individual 5mL cups (380,700 units) and 16 fl. oz. (480 mL) bubblegum-flavored bottles (14,760 units). The recall was initiated because testing revealed an impurity peak that exceeds the approved safety specifications, meaning the product contains degradation products or impurities at levels higher than allowed.

Risk

The presence of impurities above the approved limit may lead to reduced effectiveness of the medication or potential unexpected side effects, though this recall is classified as low risk.

What You Should Do

Check your medication packaging for Nystatin Oral Suspension, USP 500,000 units/5mL Cups with NDC 66689-037-50 or NDC 66689-037-99. Specifically look for lot 619800 (Exp. 12/31/2020), lot 626200 (Exp. 01/31/2021), lot 619800X (Exp. 12/31/2020), or lot 626200X (Exp. 01/31/2021).
Check your medication cabinet for Nystatin Oral Suspension, USP 100,000 units per mL (Bubblegum Flavored) 16 fl. oz. bottles with NDC 66689-008-16. Specifically look for lot 639000 with an expiration date of 10/31/2021.
If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.
Return any unused or recalled medication to the pharmacy where it was purchased for a refund.
Contact VistaPharm, Inc. at 1-888-723-3332 or visit their website at www.fda.gov/safety/recalls for more information on the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Product return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nystatin Oral Suspension, USP 500,000 units/5mL Cup (5 mL)

Model:

NDC 66689-037-50

individual cup NDC: 66689-037-01

NDC 66689-037-99

Lot Numbers:

619800 (Exp. 12/31/2020)

626200 (Exp. 01/31/2021)

619800X (Exp. 12/31/2020)

626200X (Exp. 01/31/2021)

Date Ranges: 12/31/2020, 01/31/2021

Product: Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored (16 fl. oz. / 480 mL)

Model:

NDC 66689-008-16

Lot Numbers:

639000 (Exp. 10/31/2021)

Date Ranges: 10/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85888

Status: Resolved

Manufacturer: VistaPharm, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (380,700 cups; 14,760 bottles)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Nystatin Oral Suspension, USP 500,000 units/5mL Cups with NDC 66689-037-50 or NDC 66689-037-99. Specifically look for lot 619800 (Exp. 12/31/2020), lot 626200 (Exp. 01/31/2021), lot 619800X (Exp. 12/31/2020), or lot 626200X (Exp. 01/31/2021).

Check your medication cabinet for Nystatin Oral Suspension, USP 100,000 units per mL (Bubblegum Flavored) 16 fl. oz. bottles with NDC 66689-008-16. Specifically look for lot 639000 with an expiration date of 10/31/2021.

If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.

Return any unused or recalled medication to the pharmacy where it was purchased for a refund.

Contact VistaPharm, Inc. at 1-888-723-3332 or visit their website at www.fda.gov/safety/recalls for more information on the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Nystatin Oral Suspension, USP 500,000 units/5mL Cup (5 mL)

Model:

NDC 66689-037-50

individual cup NDC: 66689-037-01

NDC 66689-037-99

Lot Numbers:

619800 (Exp. 12/31/2020)

626200 (Exp. 01/31/2021)

619800X (Exp. 12/31/2020)

626200X (Exp. 01/31/2021)

Date Ranges: 12/31/2020, 01/31/2021

Product: Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored (16 fl. oz. / 480 mL)

Model:

NDC 66689-008-16

Lot Numbers:

639000 (Exp. 10/31/2021)

Date Ranges: 10/31/2021