Information
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Fluocinolone Acetonide Solution Topical Solution USP
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0256-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Fluocinolone Acetonide Solution Topical Solution USP
SUN PHARMACEUTICAL INDUSTRIES INC · Class III — Regulatory
Product Description
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide within the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
SUN PHARMACEUTICAL INDUSTRIES INC initiated a Class III recall of a pharmaceutical product on December 30, 2025 affecting 24,624 bottles. Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.