FDA recall D-0256-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Class III · drug

Product

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.

Distribution

Nationwide within the USA

Key facts

Status: Ongoing
Initiation date: 2025-12-30
Report date: 2026-01-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0256-2026