Diclofenac Sodium Gel
FDA Recall NDC 76282-103
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 Diclofenac Sodium (NDC 76282-103). A significant event, classified as Class III, was initiated on Dec 22, 2025 by Exelan Pharmaceuticals Inc.. The reported reason for this action was: "Failed PH 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 III Ongoing
Failed PH Specifications
Dec 22, 2025
Jan 28, 2026
92,376 tubes
Recall Profile & Regulatory Data
Event ID
98193
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Batch or Lot Expiration Information
Batch# Batch XHBG; Exp. 08/31/2027
Affected Packages Involved in this Recall
76282-103-39Product
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.
