Warning
Padagis US LLC Recalls Nystatin Cream USP
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0677-2026Drug / Pharmaceutical
Padagis US LLC Recalls Nystatin Cream USP
Padagis US LLC · Class II — Moderate Risk
Product Description
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 for Recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Padagis US LLC has recalled a pharmaceutical product that the FDA classified as Class II affecting 180,936 tubes. The recall was initiated on June 23, 2026. Subpotent Drug: Low out of specification assay results performed during long-term stability testing. It was distributed in USA Nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.