VistaPharm Nystatin Oral Suspension Recall: Impurity Risk
VistaPharm recalls Nystatin Oral Suspension due to impurities exceeding safety limits. This may cause health issues. Check product labels for NDC codes 66689-008-02 or 66689-037-01, 66689-037-50, 66689-037-99.
Lower-risk recall
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Contact the company
What happened, in plain English
VistaPharm is recalling Nystatin Oral Suspension products that contain impurities beyond safe levels. This could pose health risks to users, especially those with compromised immune systems. Read more at govinfonow.com/recall/41620-vistapharm-nystatin-oral-suspension-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41620-vistapharm-nystatin-oral-suspension-recall-impurity-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0869-2017
Cite this page
“VistaPharm Nystatin Oral Suspension Recall: Impurity Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41620-vistapharm-nystatin-oral-suspension-recall-impurity-risk. Based on FDA recall #D-0869-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0869-2017%22&limit=1).
Why it’s dangerous
The product contains impurities that exceed approved safety limits. This could lead to health issues, particularly for individuals with compromised immune systems.
Who’s affected
People who have the recalled Nystatin Oral Suspension bottles or unit dose cups. Those with weakened immune systems may be at higher risk.
How to tell if you have this one
Check for NDC codes: 66689-008-02 (2 fl.oz. bottles), 66689-037-01 (500,000 units/5mL cups), 66689-037-50 (50 count cups), or 66689-037-99 (100 count cups). The products were manufactured with specific lot numbers and expiration dates.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Product Label
Look for NDC codes 66689-008-02, 66689-037-01, 66689-037-50, or 66689-037-99 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0869-2017 (May 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0869-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.