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Recall Observatory FDA recall evidence

Drug 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

D-0342-2026

January 27, 2026

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 98351
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0342-2026

Official wording

Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

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

Distribution pattern: US Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification