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

FDA recall notice · announced July 22, 2026 · Padagis Us

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 205060, Exp 09/30/2027
Quantity: 180,936 tubes
Status: Ongoing
Products in this recall event:
- 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 (D-0677-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.