Cipla USA, Inc.: Drug Recall

Recall #D-0291-2026 · 12/22/2025

Class III: Low Risk

Recall Details

Recall Number: D-0291-2026
Classification: Class III
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Ongoing
Date Initiated: 12/22/2025
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 92,376 tubes

Reason for Recall

Failed PH Specifications

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Cipla USA, Inc.

Class II: Risk 01/02/2026

Presence of Particulate Matter.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/24/2025

Failed stability specifications: Out of specification for hardness test

View all recalls by Cipla USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.