FDA Drugs recall ·

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz)… recall

Recall number
D-0291-2026
Date
(initiated December 22, 2025)
Company / brand
Cipla USA, Inc.
10 Independence Blvd, Warren, NJ, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
92,376 tubes
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

Failed PH Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Batch XHBG; Exp. 08/31/2027

Distribution

Nationwide in the USA

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0291-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.