FDA-Drug2026-01-28Class IIICHEMICAL
Cipla USA Diclofenac Sodium Topical Gel recalled for failed pH specifications
OTHERNationwide distribution
Stop using Cipla Diclofenac Sodium Topical Gel
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
Hazard
Failed PH Specifications
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 USA, Inc. recalls
- FDA-Drug2026-04-22Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
- FDA-Drug2026-04-22Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
- FDA-Drug2026-04-22Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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