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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DICLOFENAC SODIUM, EXELAN PHARMACEUTICALS INC.
- Product type
- Topical Gel
- Model numbers
- Batch XHBG, Exp. 08/31/2027
- UPC codes
- 76282-103, 76282-103-39
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 22, 2025
Reported by FDA DRUG
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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.
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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.
- Failed pH specifications
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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