Fluocinonide Gel USP — Class III drug recall D-0146-2018
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2017-11-01, distributed nationwide. Cross contamination with other products: traces of Dapsone were found in the finished product.
| Recall number | D-0146-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2017-09-20 |
| Classified | 2017-12-29 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2020-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 16,944 tubes |
| NDC | 51672-1253, 51672-1253-01, 51672-1253-02, 51672-1253-03, 51672-1253-04, 51672-1254, 51672-1254-01, 51672-1254-02, 51672-1254-03, 51672-1264, 51672-1264-01, 51672-1264-02, 51672-1264-03, 51672-1279, 51672-1279-01, 51672-1279-02, 51672-1279-03 |
| Lot numbers | 6/18, A771026850 |
Product
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Reason for recall
Cross contamination with other products: traces of Dapsone were found in the finished product.
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-0146-2018. 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.