Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only,
Pharmaceutical Associates recalls Nystatin Oral Suspension (500,000 units/5mL) for resuspension problems. This product is for institutional use only and requires a prescription.
Lower-risk recall
Resuspension problems: Out of specification for appearance and resuspendability.
Contact the company & request your remedy
What happened, in plain English
Pharmaceutical Associates is recalling Nystatin Oral Suspension (500,000 units per 5 mL) due to resuspension issues. This product is for institutional use only and requires a prescription. The recall affects specific lots manufactured in Greenville, SC. Read more at govinfonow.com/recall/40508-pharmaceutical-associates-nystatin-oral-suspension-recall-resuspension-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40508-pharmaceutical-associates-nystatin-oral-suspension-recall-resuspension-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0865-2018
Cite this page
“Pharmaceutical Associates Nystatin Oral Suspension Recall: Resuspension Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40508-pharmaceutical-associates-nystatin-oral-suspension-recall-resuspension-issues. Based on FDA recall #D-0865-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0865-2018%22&limit=1).
Why it’s dangerous
The product has resuspension problems, meaning it may not mix properly when shaken. This could affect the medication's effectiveness but does not pose a direct safety risk to users.
Who’s affected
Institutional users with prescriptions for this medication are affected. The risk is low as the product is for institutional use only and requires a prescription.
How to tell if you have this one
Check for the Nystatin Oral Suspension, 500,000 units/5 mL, packaged in 5 mL cups. The product is for institutional use only and requires a prescription. Lot numbers B5B8 with expiration 07/2019.
- Brand
Pharmaceutical Associates- Category
Drug
What to do — step by step
Check Product Details
Verify the product label includes Nystatin Oral Suspension, 500,000 units/5 mL, packaged in 5 mL cups, with lot number B5B8 and expiration 07/2019.
Questions people ask
Is this product safe to use?
The product has resuspension issues but does not pose a direct safety risk. It is intended for institutional use only and requires a prescription.
What should I do if I have this product?
The recall does not specify a remedy, so check the product details and contact the manufacturer if you have concerns.
Is this product available over the counter?
No, this product is for institutional use only and requires a prescription.
Contact Pharmaceutical Associates
We’ve drafted a message you can send Pharmaceutical Associates to request your refund or repair — edit it as you like.
Subject: Recall D-0865-2018 — Pharmaceutical Associates Pharmaceutical Associates Hello, I own a Pharmaceutical Associates that is covered by recall D-0865-2018 from Pharmaceutical Associates. 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-0865-2018 (May 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0865-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.