FDA recall, , Moderate risk
Padagis Nystatin Cream
Nystatin Cream USP is subpotent, with low assay results from stability testing.
Summary by Recall Canary from the FDA notice
What happened
Padagis US LLC, of Minneapolis, Minnesota, recalled Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, manufactured by Padagis in Yeruham, Israel, because the drug is subpotent, with low out of specification assay results from long-term stability testing. The recall began June 23, 2026, and was added to the FDA's Enforcement Report on July 13, 2026.
The product was distributed nationwide in the USA. The recall involves 180,936 tubes.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Nystatin Cream USP
- NDC
- 45802-059-35
- Lot code
- 205060
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Padagis US LLCMinneapolis, Minnesota
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99283
- Recall number
- D-0677-2026
- Quantity recalled
- 180,936 tubes
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
