FDA Recall D-0342-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 107 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0342-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2026-01-27
Classified by FDA Center: 2026-02-23
FDA published: 2026-02-11
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): DICLOFENAC SODIUM
Generic name(s): DICLOFENAC SODIUM
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 51672-1363
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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