FDA Drug recall D-0477-2026
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pha…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pha… by Sun Pharmaceutical Industries, citing failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0477-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Fluocinonide, USP, 0.05% Cream, 60g 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 51672-1386-3.
Reason
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Identifiers
| ndc | 51672-1386-1 |
|---|---|
| ndc | 51672-1386-2 |
| ndc | 51672-1386-3 |
| ndc | 51672-1386-4 |
| code_info | Lot# AD76250, Exp Date: 6/30/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0477-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.