Fluocinolone Acetonide Solution Topical Solution USP — Class III drug recall D-0256-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-01-21, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity
| Recall number | D-0256-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2025-12-30 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 24,624 bottles |
| Reason classes | specification failure |
| NDC | 51672-1365, 51672-1365-02, 51672-1365-04 |
| Lot numbers | AD81290, AD81291, AD81292, AD81293 |
| Expiration dates | 2027-01-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0256-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.