VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL
VistaPharm recalls Nystatin Oral Suspension due to impurities exceeding safety limits. This may cause serious harm if used. Check your product's NDC or lot number for affected batches.
Recall notice
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Contact the company & request your remedy
What happened, in plain English
VistaPharm is recalling Nystatin Oral Suspension products that contain impurities beyond safe levels. Using these products could pose a risk of serious harm to users. Read more at govinfonow.com/recall/37001-vistapharm-nystatin-oral-suspension-recall-impurities-risk-serious-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/37001-vistapharm-nystatin-oral-suspension-recall-impurities-risk-serious-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1377-2020
Cite this page
“VistaPharm Nystatin Oral Suspension Recall: Impurities Risk Serious Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37001-vistapharm-nystatin-oral-suspension-recall-impurities-risk-serious-harm. Based on FDA recall #D-1377-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1377-2020%22&limit=1).
Why it’s dangerous
The product contains impurities that exceed approved safety limits. These impurities could cause serious harm when taken by patients. The specific impurity peak is not detailed in the recall notice.
Who’s affected
People who have the recalled Nystatin Oral Suspension product, typically prescribed by a doctor for fungal infections. Those with compromised immune systems may be at higher risk.
How to tell if you have this one
Check for NDC numbers 66689-037-50 (individual cup) or 66689-037-99. Look for lot numbers 619800 (expiring 12/31/2020) or 626200 (expiring 01/31/2021).
- Brand
VistaPharm- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
United States including Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1377-2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.; Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021. | 380,700 cups |
| D-1378-2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.; Lot # 639000, Exp. 10/31/2021 | 14,760 bottles |
What to do — step by step
Check Product Details
Identify your product's NDC number and lot number to confirm if it's affected.
Questions people ask
Is this product safe to use?
The recall states the product contains impurities exceeding approved safety limits, so it is not safe to use.
How do I know if my product is affected?
Check for NDC numbers 66689-037-50 or 66689-037-99 and lot numbers 619800 or 626200.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact VistaPharm directly for guidance.
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-1377-2020 — VistaPharm VistaPharm Hello, I own a VistaPharm that is covered by recall D-1377-2020 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-1377-2020 (June 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1377-2020 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.