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), Rx only,
Pharmaceutical Associates recalls Nystatin Oral Suspension (16 fl oz) due to subpotent drug levels. This means the medication may not be as effective as it should be. Consumers with a prescription should contact their doctor.
Lower-risk recall
Subpotent drug: Out of specification for assay at the 15-month test interval.
Contact the company & request your remedy
What happened, in plain English
Pharmaceutical Associates is recalling Nystatin Oral Suspension (16 fl oz) because it failed quality tests at 15 months. This could mean the medication isn't as effective as it should be for treating fungal infections. People with a prescription for this medication should talk to their doctor about alternatives. Read more at govinfonow.com/recall/36867-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36867-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1494-2020
Cite this page
“Pharmaceutical Associates Nystatin Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36867-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-1494-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1494-2020%22&limit=1).
Why it’s dangerous
The medication failed quality tests at the 15-month test interval, meaning it may not contain enough active ingredient. This could lead to the treatment not working as intended for fungal infections. However, the product is not unsafe to use and does not cause immediate harm.
Who’s affected
People with a prescription for Nystatin Oral Suspension (16 fl oz) from Pharmaceutical Associates. Those using the product for fungal infections are most at risk of ineffective treatment.
How to tell if you have this one
Check the product label for 'Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL), Rx only'. The lot number is B973 with an expiration date of November 2020.
- Brand
Pharmaceutical Associates- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number B973 and expiration date of November 2020 on the label.
Questions people ask
Is this product dangerous if taken?
The product is not dangerous but may not be as effective as it should be. This could lead to ineffective treatment for fungal infections.
What should I do if I have this product?
Contact your doctor to discuss alternative treatments since the product may not be as effective.
How can I tell if I have the recalled product?
Check the label for the lot number B973 and expiration date of November 2020.
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-1494-2020 — Pharmaceutical Associates Pharmaceutical Associates Hello, I own a Pharmaceutical Associates that is covered by recall D-1494-2020 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-1494-2020 (August 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1494-2020 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.