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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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.

The Hazard

The product failed to meet pH specifications, which can affect its safety and effectiveness. Using a product that does not meet these standards may lead to adverse reactions.

Reported Incidents

There are no reported injuries or adverse incidents related to this recall. However, the potential for harm remains high due to the chemical nature of the product.

What to Do

Stop using the Diclofenac Sodium Topical Gel immediately. Contact Cipla USA, Inc. or your healthcare provider for further guidance.

Contact Information

For further inquiries, consumers can visit the FDA recall page or contact Cipla USA, Inc. directly for assistance.

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

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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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