December 2025 FDA Recall Diclofenac Sodium by Cipla Usa, Inc.
D-0291-2026 - Failed PH Specifications

This Class III drug recall was voluntarily initiated by Cipla Usa, Inc. on December 22, 2025 for the product Diclofenac Sodium. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0291-2026

Reason for Recall
Failed PH Specifications
Initiated
12-22-2025
Reported
01-28-2026
Quantity
92,376 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cipla USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# Batch XHBG; Exp. 08/31/2027

Affected Packages Involved in this Recall

76282-103-39 Diclofenac Sodium