Diclofenac Sodium recalls

Diclofenac Sodium products have been recalled 3 times, most recently on 11 Feb 2026. The recalling company is usually Alembic Pharmaceuticals.

Total recalls3since 2023
Last 12 months2reported
Class I00% of total
Ongoing3latest 11 Feb 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why diclofenac sodium is recalled

Product types

By year

Ongoing diclofenac sodium recalls

3 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDiclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac SodiumSun Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIIDiclofenac Sodium Topical Gel recalled by Cipla USADiclofenac SodiumCipla USAOtherNationwide
DrugCLASS IIDiclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac SodiumAlembic PharmaceuticalsOtherNationwide

All diclofenac sodium recalls, newest first

3 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDiclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac SodiumSun Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIIDiclofenac Sodium Topical Gel recalled by Cipla USADiclofenac SodiumCipla USAOtherNationwide
DrugCLASS IIDiclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac SodiumAlembic PharmaceuticalsOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.