FDA recall D-0677-2026

Padagis US LLC · Class II · drug

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.

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-06-23
Report date
2026-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0677-2026