Padagis Us Llc: Nystatin Cream Usp, (100,000 Usp Nystatin Units)

Padagis US LLC is recalling Nystatin Cream USP (100,000 USP Nystatin Units) in 15-gram tubes nationwide because testing found the medication contains less active ingredient than it should. The affected product was manufactured by Padagis in Yeruham, Israel and distributed across all U.S. states. This is a Class II recall, meaning the product may not work as intended but is unlikely to cause serious harm.

Recalling firm

Padagis US LLC

Product

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

Reason

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-23

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/4f9770ff-a97b-4bde-96f2-9813bf8d8d12