MEDIUM

Taro Pharmaceuticals Withdraws Diclofenac Sodium Gel Over Viscosity Issues

Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
February 9, 2026
Hazard Level
MEDIUM
Brands
CETRORELIX ACETATE, Meitheal Pharmaceuticals Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Defective delivery system.

What You Should Do

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

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Product Details

The affected product is Diclofenac Sodium, Topical Gel, 3% in 100 g tubes. It was manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada. Lot numbers include AD92720, AD92722, and AD92723, with an expiration date of March 31, 2027.

The Hazard

The viscosity of Diclofenac Sodium Gel, 3% does not meet specifications. This could affect the efficacy of the medication, posing a risk to users.

Reported Incidents

No specific incidents or injuries have been reported related to this withdrawal. The company has initiated this action purely as a precaution.

What to Do

Stop using the product immediately. Contact Sun Pharmaceutical Industries Inc. or your healthcare provider for further guidance on this issue.

Contact Information

For questions, consumers can reach Sun Pharmaceutical Industries at their official website or contact their healthcare provider for more information.

Key Facts

  • Market withdrawal initiated on January 27, 2026
  • Product does not meet viscosity specifications
  • No reported injuries related to this withdrawal
  • Stop using the product immediately

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Safety Assessment

Risk LevelMEDIUM
Severity Score
4/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot Q4E0112A
Exp.: 30 Apr 2027
UPC Codes
71288-558
71288-558-90
71288-556-02
+1 more
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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