FDA-Drug2026-01-28Class IIICHEMICAL
Cipla USA Diclofenac Sodium Topical Gel recalled for failed pH specifications
What this means
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.
- Stop using this gel if you have batch XHBG with expiration date 08/31/2027
- Check the batch number on your tube
- Contact your pharmacy or doctor for a replacement or alternative pain relief option
- Return unused gel to your pharmacy
The agency's original wording
Hazard
Failed PH Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
92,376 tubes
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2026More Cipla recalls
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
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