Nystatin Cream
FDA Recall NDC 45802-059
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nystatin (NDC 45802-059). A significant event, classified as Class II, was initiated on Jun 23, 2026 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "Subpotent Drug: Low out of specification assay results performed during long-term stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Jun 23, 2026
Jul 22, 2026
180,936 tubes
Recall Profile & Regulatory Data
Event ID
99283
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Padagis US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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
Batch or Lot Expiration Information
Lot# : 205060, Exp 09/30/2027
Affected Packages Involved in this Recall
45802-059-35Product
45802-059-11Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
