Recall: D-0256-2026

Class III - Minor Violations

Class IIIClassification

2025-12-30Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Distribution

Nationwide within the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.