Diclofenac Sodium recall
FDA recall D-0342-2026 · initiated Jan 27, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Diclofenac Sodium in Jan 2026 — an FDA Class II recall (D-0342-2026) because Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
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: N/A
Details
- Product
- Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jan 27, 2026
- FDA report date
- Feb 11, 2026
Frequently asked
- Was Diclofenac Sodium recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Diclofenac Sodium in Jan 2026 — an FDA Class II recall (D-0342-2026) because Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Diclofenac Sodium recalled?
- Per the FDA enforcement record, the reason for recall D-0342-2026 was: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- Is a recalled Diclofenac Sodium 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # AD92721, Exp Date: 3/31/2027.. 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-0342-2026.