Diclofenac Sodium Topical Gel recall
FDA recall D-0291-2026 · initiated Dec 22, 2025
Cipla USA, Inc. recalled Diclofenac Sodium Topical Gel in Dec 2025 — an FDA Class III recall (D-0291-2026) because Failed PH Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed PH Specifications
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 92,376 tubes
Details
- 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
- Recalling company
- Cipla Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 22, 2025
- FDA report date
- Jan 28, 2026
Frequently asked
- Was Diclofenac Sodium Topical Gel recalled?
- Cipla USA, Inc. recalled Diclofenac Sodium Topical Gel in Dec 2025 — an FDA Class III recall (D-0291-2026) because Failed PH Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Diclofenac Sodium Topical Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0291-2026 was: Failed PH Specifications
- Is a recalled Diclofenac Sodium Topical Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Diclofenac Sodium Topical Gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Batch XHBG; Exp. 08/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0291-2026.