VistaPharm, Inc. recalls NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose
VistaPharm recalls NYSTATIN Oral Suspension due to impurities failing quality specifications. This medication is for prescription use only and may pose health risks if consumed.
Recall notice
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Contact the company & request your remedy
What happened, in plain English
VistaPharm is recalling a specific batch of NYSTATIN Oral Suspension because it contains impurities that didn't meet safety standards. This could potentially cause health issues if taken as directed. Read more at govinfonow.com/recall/39400-vistapharm-nystatin-oral-suspension-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39400-vistapharm-nystatin-oral-suspension-recall-impurities-may-cause-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-0348-2019
Cite this page
“VistaPharm NYSTATIN Oral Suspension Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39400-vistapharm-nystatin-oral-suspension-recall-impurities-may-cause-harm. Based on FDA recall #D-0348-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2019%22&limit=1).
Why it’s dangerous
The medication failed impurities and degradation specifications, meaning it may contain harmful substances not supposed to be present. This could lead to health risks if consumed.
Who’s affected
Prescription patients who received this specific batch of NYSTATIN Oral Suspension from VistaPharm. Those with the medication's NDC codes listed are most at risk.
How to tell if you have this one
Check for the NDC codes 66689-037-50 or 66689-037-99 on the packaging. The product is a prescription-only oral suspension in 5ml cups, sold in packs of 50 or 100 unit doses.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC codes 66689-037-50 or 66689-037-99 on the packaging to confirm if you have the recalled batch.
Questions people ask
Is this medication safe to use?
The official recall states the product failed impurities and degradation specifications, so it is not safe to use as it may contain harmful substances.
What should I do if I have this medication?
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to stop using it.
How can I tell if I have the recalled product?
Check for the NDC codes 66689-037-50 or 66689-037-99 on the packaging. The product is a prescription-only oral suspension in 5ml cups.
Contact VistaPharm
We’ve drafted a message you can send VistaPharm to request your refund or repair — edit it as you like.
Subject: Recall D-0348-2019 — VistaPharm VistaPharm Hello, I own a VistaPharm that is covered by recall D-0348-2019 from VistaPharm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0348-2019 (November 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0348-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.