Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz)
Recalled by Cipla USA, Inc.
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Cipla USA, Inc. has recalled Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 28, 2026 and was initiated on December 22, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), with approximately 92,376 tubes affected. The company behind the recall is Cipla USA, Inc., based in Warren, NJ. The FDA describes the product as: “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 Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz) recalled?
According to the FDA, the stated reason for the recall is: “Failed PH Specifications.”
What should you do?
If you think you may have bought Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), compare it against the product description and identifying codes (Batch XHBG; Exp. 08/31/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Cipla USA, Inc. or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- January 28, 2026
- Recall started
- December 22, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz) recalled?+
According to the FDA: Failed PH Specifications
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz)?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0291-2026. Information last synced from the FDA on July 5, 2026.