Clindamycin Phosphate Solution
FDA Recall NDC 51672-4081
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 Clindamycin Phosphate (NDC 51672-4081). A significant event, classified as Class III, was initiated on Nov 26, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay."
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 III Ongoing
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Nov 26, 2025
Jan 21, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98062
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Batch or Lot Expiration Information
Lot# : AD30154, AD31143, AD31145, Exp 11/30/2025
Affected Packages Involved in this Recall
51672-4081-3Product
51672-4081-4Product
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.
