VistaPharm Nystatin Oral Suspension Recall: Impurity Risk
VistaPharm recalls Nystatin Oral Suspension (NDC 66689-037-01) due to impurity issues detected at 18 months. Rx-only product with specific lots and expiration dates.
Recall notice
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Contact the company
What happened, in plain English
VistaPharm has recalled Nystatin Oral Suspension (5 mL, 500,000 units) because tests found impurities that could degrade the product. This affects prescription-only medication with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/46848-vistapharm-nystatin-oral-suspension-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/46848-vistapharm-nystatin-oral-suspension-recall-impurity-risk · Updated August 20, 2026 · FDA enforcement record: FDA #D-913-2013
Cite this page
“VistaPharm Nystatin Oral Suspension Recall: Impurity Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/46848-vistapharm-nystatin-oral-suspension-recall-impurity-risk. Based on FDA recall #D-913-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-913-2013%22&limit=1).
Why it’s dangerous
The product failed impurity tests at 18 months, indicating potential degradation that could affect safety. This is a quality issue that may not cause immediate harm but requires attention due to the medication's purpose.
Who’s affected
Prescription patients who received Nystatin Oral Suspension with the listed lot numbers (240200, 243000, etc.) and expiration date 06/13. Those using the product for fungal infections may be at risk.
How to tell if you have this one
Check the product label for Nystatin Oral Suspension (5 mL, 500,000 units) with NDC 66689-037-01. Look for lot numbers 240200, 243000, 244800, 245600, 250800, or 253600 and expiration date 06/13.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 66689-037-01 and specific lot numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-913-2013 (July 4, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-913-2013 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.