HIGH

DPT Laboratories Recalls Diclofenac Sodium Gel Over PH Specification Failure

DPT Laboratories recalled 92,376 tubes of Diclofenac Sodium Topical Gel, 1%, on December 22, 2025. The recall is due to the product failing pH specifications, posing a high risk to consumers. Users should stop using the gel immediately and contact healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
December 22, 2025
Hazard Level
HIGH
Brands
DICLOFENAC SODIUM, EXELAN PHARMACEUTICALS INC.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed PH Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

Diclofenac Sodium Topical Gel is a non-steroidal anti-inflammatory drug (NSAID) commonly used to relieve pain and inflammation. Consumers purchase this product for conditions such as arthritis, muscle pain, and joint pain.

Why This Is Dangerous

The product's failure to meet pH specifications may compromise its safety and efficacy, potentially leading to skin irritation or other adverse reactions. Users should refrain from using any recalled product until further guidance is provided.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers who have purchased this gel may experience inconvenience due to the need to cease use and seek alternatives for pain relief. The financial impact includes the need to purchase a different product while waiting for a refund.

Practical Guidance

How to identify if yours is affected

  1. Locate the product packaging and check for the NDC 76282-103-39.
  2. Verify the batch number XHBG to confirm if your product is affected.
  3. Check the expiration date to ensure it falls before the recall date.

Where to find product info

The NDC can typically be found on the product's primary packaging, while the batch number is usually printed on the tube or box.

What timeline to expect

Expect the refund or replacement process to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Contact Cipla USA, Inc. again and document your communications.
  • Reach out to the FDA for assistance if the company does not respond.

How to prevent similar issues

  • Always check for recalls on products before use.
  • Look for FDA approval and certifications when purchasing medications.
  • Be cautious of products that do not meet safety standards.

Documentation advice

Keep copies of your receipts, any correspondence with the company, and photographs of the product for your records.

Product Details

The recalled Diclofenac Sodium Topical Gel is packaged in 100 g (3.53 oz) tubes. The NDC is 76282-103-39. The product was distributed nationwide in the USA.

Key Facts

  • Recall date: December 22, 2025
  • Total units recalled: 92,376
  • Manufactured by: DPT Laboratories, Ltd.
  • Product NDC: 76282-103-39
  • Failed pH specifications

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Batch XHBG
Exp. 08/31/2027
UPC Codes
76282-103
76282-103-39
Affected States
ALL
Report Date
January 28, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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