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
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Low |
| Status | ongoing |
| Recall date | December 30, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Country / region | United States NJ |
Hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Affected products
- 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
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