UnratedDrug recall · FDA · Published December 22, 2025
Cipla Diclofenac Gel Recall: Failed PH Specifications Risk
Cipla USA recalls 1% Diclofenac Sodium Topical Gel due to failed pharmaceutical specifications. Consumers should check NDC 76282-103-39 and batch XHBG for affected units.
“Cipla Diclofenac Gel Recall: Failed PH Specifications Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31601-cipla-diclofenac-gel-recall-failed-ph-specifications-risk. Based on FDA recall #D-0291-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0291-2026%22&limit=1).
The FDA announced on Dec. 22, 2025, that Cipla USA, Inc. is voluntarily recalling Diclofenac Sodium Topical Gel due to failed pH specifications. The recall affects 92,376 tubes distributed nationwide.
How to tell if you have it
Brand: Cipla
Product: Diclofenac Sodium Topical Gel, 1%
Size: NET WT 100 g (3.53 oz)
NDC: 76282-103-39
Batch: XHBG
Expiration: 08/31/2027
Manufacturer: DPT Laboratories, Ltd.
The hazard
The product failed pH specifications. The FDA stated this is a Class III recall.
Context
GovInfoNow's records show Cipla USA, Inc. has 12 other recalls on record since June 27, 2023. Other recent recalls of similar products include Sun Pharmaceutical Diclofenac Gel Recall (Jan. 27, 2026) and Water-Jel Lidocaine Wound Gel Recall (April 7, 2026), both citing failed pH specifications. Cipla also issued a Cinacalcet Tablets Recall on June 29, 2026, for N-nitroso-cinacalcet risk.
How to tell if you have this one
Check for NDC code 76282-103-39 and batch number XHBG on the product label. The gel was manufactured by DPT Laboratories, Ltd. in San Antonio, TX and expires August 31, 2027.
Brand
Cipla
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for NDC 76282-103-39 and batch XHBG on the gel container.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0291-2026 (December 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0291-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.