Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 5, 2020

Summary

VistaPharm, Inc. is recalling 14,244 bottles of Nystatin Oral Suspension, USP (100,000 units per mL), a bubblegum-flavored liquid medication used to treat fungal infections. This recall was initiated because testing for one specific lot showed results for an impurity that exceeded the approved safety and quality specifications. Approximately 14,244 bottles (16 fl. oz. size) were distributed nationwide to pharmacies and healthcare providers.

Risk

The product failed to meet the required specifications for impurities and degradation products. While the specific health risk level is categorized as low, impurities in medication can affect the drug's safety, potency, and effectiveness over time.

What You Should Do

Check your medicine cabinet for 16 fl. oz. (480 mL) bottles of Nystatin Oral Suspension, USP 100,000 units per mL (Bubblegum Flavored).
Look for lot number 638800 with an expiration date of 10/21 printed on the label to see if your bottle is part of the recall.
Verify the NDC (National Drug Code) 66689-008-16 and UPC 6668900816 located on the product packaging.
Contact your healthcare provider or pharmacist for guidance if you are currently using this medication or have used it recently.
Return any unused product from the affected lot to your pharmacy for a refund and contact VistaPharm, Inc. for further instructions.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy 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 100,000 units per mL (Bubblegum Flavored) 16 fl. oz. (480 mL)

Model:

NDC 66689-008-16

UPC Codes:

6668900816

Lot Numbers:

638800 (Exp 10/21)

Date Ranges: Exp 10/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86486

Status: Resolved

Manufacturer: VistaPharm, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 14,244 16 oz 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 medicine cabinet for 16 fl. oz. (480 mL) bottles of Nystatin Oral Suspension, USP 100,000 units per mL (Bubblegum Flavored).

Look for lot number 638800 with an expiration date of 10/21 printed on the label to see if your bottle is part of the recall.

Verify the NDC (National Drug Code) 66689-008-16 and UPC 6668900816 located on the product packaging.

Contact your healthcare provider or pharmacist for guidance if you are currently using this medication or have used it recently.

Return any unused product from the affected lot to your pharmacy for a refund and contact VistaPharm, Inc. for further instructions.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.