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.
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
- Locate the product packaging and check for the NDC 76282-103-39.
- Verify the batch number XHBG to confirm if your product is affected.
- 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.