Nystatin Cream
FDA Recall NDC 51672-1289
Latest: Not Yet Classified · Status: Ongoing · Initiated Sep 14, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nystatin (NDC 51672-1289). A significant event, classified as Not Yet Classified, was initiated on Sep 14, 2026 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Stability Specifications"
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
Not Yet Classified Ongoing
Failed Stability Specifications
Sep 14, 2026
Sep 23, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99876
Classification
Not Yet Classified
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1
Batch or Lot Expiration Information
Lot# LOT AD49605, LOT AD49606; Exp. 05/31/2027
Affected Packages Involved in this Recall
51672-1289-1Nystatin
51672-1289-2Nystatin
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.
