Recalling firm
Padagis US LLC
Product type
Drug
Status
Ongoing
Report date
2026-07-22
Distribution
USA Nationwide
Firm state
MN
Product quantity
180,936 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
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
Code / lot info
Lot #: 205060, Exp 09/30/2027
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.