Akorn, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc.,
Akorn recalls Nystatin Oral Suspension (Rx only) due to potential impurities found during stability testing. Consumers should contact the manufacturer for details.
Recall notice
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Nyst: a prescription oral suspension for impurities detected during stability testing. This could pose a risk to health if the impurity is harmful. Read more at govinfonow.com/recall/39067-akorn-nystatin-oral-suspension-recall-unknown-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39067-akorn-nystatin-oral-suspension-recall-unknown-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1080-2019
Cite this page
“Akorn Nystatin Oral Suspension Recall: Unknown Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39067-akorn-nystatin-oral-suspension-recall-unknown-impurity-risk. Based on FDA recall #D-1080-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1080-2019%22&limit=1).
Why it’s dangerous
The stability testing found an unknown impurity that didn't meet quality standards. This could mean the product might contain harmful substances that could cause health issues.
Who’s affected
Prescription patients using Nystatin Oral Suspension from Akorn. Those with the specific lot number 356527 are most at risk.
How to tell if you have this one
Check for the product name 'Nystatin Oral Suspension, USP', lot number 356527, and expiration date 3/19. The product is prescription-only and sold by HI-TECH Pharmacal Co., Inc.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 356527 and expiration date 3/19 on the product label.
Questions people ask
Is this product safe to use?
The recall states an unknown impurity was found during testing, but it does not specify if the product is safe to use.
What should I do if I have this product?
The recall does not provide specific action steps for consumers.
How can I get more information?
Contact Akorn directly for details about the recall.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1080-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1080-2019 from Akorn. 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-1080-2019 (March 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1080-2019 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.