Taro Nystatin Cream
Nystatin Cream, USP, failed stability specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
SUN PHARMACEUTICAL INDUSTRIES INC, of Princeton, New Jersey, recalled Nystatin Cream, USP, because it failed stability specifications. The recall, which began September 14, 2026, was added to the FDA's Enforcement Report on September 15, 2026, and classified on September 25, 2026. The product was distributed nationwide.
Summary by Recall Canary from the FDA notice.
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 your tube affected?
2 products
Affected if its lot code and NDC are listed under that product.
Nystatin Cream, USP, 15 g per tube, Rx only
- NDC
- 51672-1289-1
- Lot
- AD49605
- AD49606
Nystatin Cream, USP, 100,000 units/g, 15 g (
- NDC
- 51672-1289-1
- 51672-1289-2
- Lot
- AD49605
- AD49606
Details
- Company began the recall
- Sold in
U.S. Nationwide.
- Event ID
- 99876
- Recall No.
- N/A
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Failed specifications
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
