Clobetasol Propionate Cream
FDA Recall NDC 68180-956
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Clobetasol Propionate (NDC 68180-956). A significant event, classified as Class II, was initiated on Aug 03, 2026 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed content uniformity 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
Class II Ongoing
Failed content uniformity specifications.
Aug 03, 2026
Sep 02, 2026
5082 tubes
Recall Profile & Regulatory Data
Event ID
99544
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Batch or Lot Expiration Information
Lot# : KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Affected Packages Involved in this Recall
68180-956-01Product
68180-956-02Product
68180-956-03Product
68180-956-04Product
Class III Terminated
Subpotent Drug: Low assay result observed during long-term stability testing.
Jan 20, 2023
Feb 01, 2023
5720 tubes
Recall Profile & Regulatory Data
Event ID
91532
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jan 16, 2024
Product Description
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Batch or Lot Expiration Information
Lot# : K101033; Exp 6/2024
Affected Packages Involved in this Recall
68180-956-01Product
68180-956-02Product
68180-956-03Product
68180-956-04Product
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.
