FDA Drug recall D-0146-2018
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class III recall of Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc by Taro Pharmaceuticals U, citing cross contamination with other products: traces of Dapsone were found in the finished product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0146-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-20 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
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
Cross contamination with other products: traces of Dapsone were found in the finished product.
Identifiers
| ndc | 51672-1253-1 |
|---|---|
| ndc | 51672-1253-2 |
| ndc | 51672-1253-3 |
| ndc | 51672-1253-4 |
| ndc | 51672-1254-1 |
| ndc | 51672-1254-2 |
| ndc | 51672-1254-3 |
| ndc | 51672-1279-1 |
| ndc | 51672-1279-2 |
| ndc | 51672-1279-3 |
| ndc | 51672-1264-1 |
| ndc | 51672-1264-2 |
| ndc | 51672-1264-3 |
| code_info | Lot #: A771026850, Exp 6/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Taro Pharmaceuticals U
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FDA Drug · Class III · 2022-04-06 · Taro Pharmaceuticals U - Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dis…
FDA Drug · Class I · 2022-01-19 · Taro Pharmaceuticals U - Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class II · 2021-02-10 · Taro Pharmaceuticals U - Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0146-2018%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.