PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai
Pharmaceutical Associates recalls Nystatin Oral Suspension bottles with low assay results. This subpotent drug may not contain enough active ingredient for effective treatment. Contact for return instructions.
Lower-risk recall
SubPotent Drug: Low out-of-specification results for assay testing.
Contact the company & request your remedy
What happened, in plain English
Pharmaceutical Associates is recalling Nyst: a prescription oral suspension that may have low drug potency. This means the product might not work as intended for treating fungal infections. Read more at govinfonow.com/recall/37296-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37296-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1060-2020
Cite this page
“Pharmaceutical Associates Nystatin Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37296-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-1060-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1060-2020%22&limit=1).
Why it’s dangerous
The product may have low levels of the active ingredient due to testing issues. This could lead to ineffective treatment if the medication doesn't contain enough nystatin to fight infections.
Who’s affected
Prescription patients using Nystatin Oral Suspension for fungal infections. Those with specific medical conditions requiring precise dosing may be at higher risk.
How to tell if you have this one
Check for the 16 fl oz (473 mL) bottle with cherry or peppermint flavor. The product is prescription-only and has NDC 0121-0810-16. Lot number BE85 expired November 2020.
- Brand
Pharmaceutical Associates- Category
Drug
What to do — step by step
Check Product Details
Verify the product label includes the 16 fl oz bottle with cherry or peppermint flavor.
Questions people ask
Is this product safe to use?
The product may have low drug potency, so it might not work as intended for treating fungal infections. Consult your doctor before using.
How do I know if I have the recalled product?
Check for the 16 fl oz (473 mL) bottle with cherry or peppermint flavor, NDC 0121-0810-16, and lot number BE85 expiring November 2020.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Pharmaceutical Associates for guidance.
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-1060-2020 — Pharmaceutical Associates Pharmaceutical Associates Hello, I own a Pharmaceutical Associates that is covered by recall D-1060-2020 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-1060-2020 (March 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1060-2020 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.