January 2026 FDA Recall Diclofenac Sodium by Sun Pharmaceutical Industries Inc
D-0342-2026 - Failed Viscosity Specifications

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on January 27, 2026 for the product Diclofenac Sodium. The FDA reported the reason for recall as failed viscosity specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0342-2026

Reason for Recall
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Initiated
01-27-2026
Reported
02-11-2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98351
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7

Batch or Lot Expiration Information

Lot# AD92721, Exp Date: 3/31/2027.

Affected Packages Involved in this Recall

51672-1363-3 Diclofenac Sodium
51672-1363-7 Diclofenac Sodium