Information
Cipla USA Recalls Diclofenac Sodium Topical Gel
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0291-2026Drug / Pharmaceutical
Cipla USA Recalls Diclofenac Sodium Topical Gel
Cipla USA, Inc. · Class III — Regulatory
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
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Cipla USA, Inc. initiated a Class III recall of a pharmaceutical product on December 22, 2025 affecting 92,376 tubes. Failed PH Specifications. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects and Cipla USA recalls.