Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai,
Pharmaceutical Associates recalls Nystatin Oral Suspension (16 fl oz) due to subpotent levels. This may not contain enough active ingredient for effective treatment. Consumers should contact the manufacturer for details.
Lower-risk recall
Subpotent: Out of specification for assay at the 12-month time point.
Contact the company & request your remedy
What happened, in plain English
Pharmaceutical Associates is recalling Nystatin Oral Suspension (16 fl oz) because it may not contain enough active ingredient (subpotent) at the 1:12 month mark. This could lead to ineffective treatment if used as directed. Read more at govinfonow.com/recall/37472-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37472-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0824-2020
Cite this page
“Pharmaceutical Associates Nystatin Oral Suspension Recall: Subpotent Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37472-pharmaceutical-associates-nystatin-oral-suspension-recall-subpotent-risk. Based on FDA recall #D-0824-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0824-2020%22&limit=1).
Why it’s dangerous
The product may have lower-than-stated levels of the active ingredient (nystatin) at the 12-month mark. This subpotent issue could result in the medication being less effective for treating fungal infections.
Who’s affected
Prescription patients using Nystatin Oral Suspension (16 fl oz) with NDC 0121-0810-16 and lots BB70 or BB71 expiring May 2020 are affected. Patients on this medication for fungal infections are most at risk.
How to tell if you have this one
Check for the product name 'Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL)'. Look for NDC code 0121-0810-16 and lots BB70 or BB71 expiring May 2020.
- Brand
Pharmaceutical Associates- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Pharmaceutical Associates, Inc. at their Greenville, SC location for specific recall details and instructions.
Questions people ask
Is this product safe to use?
The product may not contain enough active ingredient for effective treatment, so it is not recommended for use.
How can I check if I have the recalled product?
Check for the NDC code 0121-0810-16 and lots BB70 or BB71 expiring May 2020 on the product label.
What should I do if I have this product?
Contact Pharmaceutical Associates, Inc. for specific instructions on what to do with the recalled product.
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-0824-2020 — Pharmaceutical Associates Pharmaceutical Associates Hello, I own a Pharmaceutical Associates that is covered by recall D-0824-2020 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-0824-2020 (January 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0824-2020 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.