VistaPharm, Inc. recalls NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)
VistaPharm recalls NYSTATIN oral suspension due to impurity in one lot. Consumers should check NDC 66689-008-16 and lot numbers for affected products.
Lower-risk recall
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Contact the company & request your remedy
What happened, in plain English
VistaPharm is recalling a specific batch of NYSTATIN oral suspension because it contains an impurity that failed quality specifications. This could pose a risk to users, though the exact health impact isn't specified in the recall. Read more at govinfonow.com/recall/36761-vistapharm-nystatin-oral-suspension-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36761-vistapharm-nystatin-oral-suspension-recall-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0019-2021
Cite this page
“VistaPharm NYSTATIN Oral Suspension Recall: Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36761-vistapharm-nystatin-oral-suspension-recall-impurity-risk. Based on FDA recall #D-0019-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0019-2021%22&limit=1).
Why it’s dangerous
The product contains an impurity that failed quality specifications in one lot. This could potentially affect safety, but the recall does not specify the exact health risk or how severe it is.
Who’s affected
People who own or use the recalled NYSTATIN oral suspension (16 fl. oz. bubblegum flavored) with NDC 66689-008-16 and lot number 638800. Those with the product are most at risk.
How to tell if you have this one
Check for the NDC code 66689-008-16 and lot number 638800 on the product label. The product is bubblegum flavored, 16 fl. oz. (480 mL) of NYSTATIN oral suspension.
- Brand
VistaPharm- Product
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 66689-008-16 and lot number 638800 on the bottle.
Questions people ask
Is this product safe to use?
The recall states there was an impurity issue in one lot, but it does not specify if the product is safe for use.
What should I do if I have this product?
The recall does not provide a remedy, so no specific action is required beyond checking the label.
How can I confirm if my product is affected?
Check for NDC 66689-008-16 and lot number 638800 on the product label.
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-0019-2021 — VistaPharm NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Hello, I own a NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) that is covered by recall D-0019-2021 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-0019-2021 (September 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0019-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.