Drug FDA Class III Ongoing Failed specifications

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

Cipla USA, Inc. Published Jan 28, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Cipla USA, Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed PH Specifications

Hazards

Failed pH Specification · primary

Affected products (1)

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

DICLOFENAC SODIUM · 92,376 tubes

NDC: 76282-103, 76282-103-39

Code info: Batch XHBG; Exp. 08/31/2027

Affected areas

Nationwide

Timeline

Initiated

Dec 22, 2025
Published

Jan 28, 2026

Recall number: D-0291-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.