Perrigo Recalls Nystatin Powder Due to Labeling Error
Perrigo recalls Nystatin, USP Powder for Rx compounding due to a label error on declared strength. Check your lot number and expiration date.
Use caution until it’s fixed
Labeling: label error on declared strength.
Contact the company
What happened, in plain English
Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding because the label contains an error regarding the declared strength. The affected product was packaged in Minneapolis, MN, and distributed nationwide. This recall involves a Class II violation where the labeling does not match the actual contents. Read more at govinfonow.com/recall/43220-perrigo-recalls-nystatin-powder-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/43220-perrigo-recalls-nystatin-powder-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0651-2016
Cite this page
“Perrigo Recalls Nystatin Powder Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43220-perrigo-recalls-nystatin-powder-due-to-labeling-error. Based on FDA recall #D-0651-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0651-2016%22&limit=1).
Why it’s dangerous
The primary hazard is a labeling error on the declared strength of the powder. If healthcare providers rely on the incorrect label information, they might compound medications with the wrong dosage, potentially leading to ineffective treatment or other medical complications for patients.
Who’s affected
Healthcare professionals and pharmacies that compound prescriptions using this specific Nystatin powder are affected. Patients receiving compounded medications containing this ingredient may be at risk if the incorrect strength was used in their treatment.
How to tell if you have this one
Look for Nystatin, USP Powder for Rx compounding, 50 Million Units, packaged by Perrigo in Minneapolis, MN. The specific item has NDC 0574-0405-05, UPC 305740404058, Lot # 2015050194, and an expiration date of 2/2016.
- Brand
Perrigo- Product
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0651-2016 | Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.; Lot #: 2015050194, Exp 2/2016 | 948 units |
| D-0652-2016 | Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157; Lot #: 2015080484, Exp 02/2016 | 918 units |
What to do — step by step
Check Inventory
Verify if you have Nystatin, USP Powder with Lot # 2015050194, Exp 2/2016, NDC 0574-0405-05.
Contact Supplier
Since the remedy is not stated in the record, contact your supplier or Perrigo directly for instructions on how to handle this recalled lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0651-2016 (January 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0651-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.