Moderate riskFDA DrugClass III

Cipla diclofenac sodium gel recalled for failed pH specifications

Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.

From the FDA notice · Read the official notice ↗ · All Cipla recalls

What to do

  1. Stop using this gel if you have batch XHBG with expiration date 08/31/2027
  2. Check the batch number on your tube
  3. Contact your pharmacy or doctor for a replacement or alternative pain relief option
  4. Return unused gel to your pharmacy

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
92,376 tubes
Illnesses reported
None reported
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Classification
Class III
Recall number
D-0291-2026

In the FDA's words

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 Failed PH Specifications Batch XHBG; Exp. 08/31/2027 Distribution: Nationwide in the USA Affected quantity: 92,376 tubes
Hazard
Failed PH Specifications

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