Fluocinonide — Class II drug recall D-0476-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-04-22, distributed nationwide. Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, no
| Recall number | D-0476-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-03-25 |
| Classified | 2026-04-13 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 41,712 |
| Reason classes | specification failure |
| NDC | 51672-1386, 51672-1386-01, 51672-1386-02, 51672-1386-03, 51672-1386-04 |
| Lot numbers | AD76251 |
| Expiration dates | 2026-06-30 |
Product
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Reason for recall
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
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-0476-2026. 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.