Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd...

FDA Recall #D-0291-2026 — Class III — December 22, 2025

Recall #D-0291-2026 Date: December 22, 2025 Classification: Class III Status: Ongoing

Product Description

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

Reason for Recall

Failed PH Specifications

Recalling Firm

Cipla USA, Inc. — Warren, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

92,376 tubes

Distribution

Nationwide in the USA

Code Information

Batch XHBG; Exp. 08/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated