Fluocinonide Cream
FDA Recall NDC 51672-1386
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fluocinonide (NDC 51672-1386). A significant event, classified as Class II, was initiated on Mar 25, 2026 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during 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
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Mar 25, 2026
Apr 22, 2026
24,672 15 g tubes
Recall Profile & Regulatory Data
Event ID
98677
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Batch or Lot Expiration Information
Lot# AD76252, Exp Date: 6/30/2026.
Affected Packages Involved in this Recall
51672-1386-1Product
51672-1386-2Product
51672-1386-3Product
51672-1386-4Product
Class II Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Mar 25, 2026
Apr 22, 2026
41,712 30g tubes
Recall Profile & Regulatory Data
Event ID
98677
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Batch or Lot Expiration Information
Lot# AD76251, Exp Date: 6/30/2026.
Affected Packages Involved in this Recall
51672-1386-1Product
51672-1386-2Product
51672-1386-3Product
51672-1386-4Product
Class II Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Mar 25, 2026
Apr 22, 2026
2,640 60g tubes
Recall Profile & Regulatory Data
Event ID
98677
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Batch or Lot Expiration Information
Lot# AD76250, Exp Date: 6/30/2026.
Affected Packages Involved in this Recall
51672-1386-1Product
51672-1386-2Product
51672-1386-3Product
51672-1386-4Product
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.
