FDA Drug recall D-0163-2016
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only by Valeant Pharmaceuticals North America, citing failed Dissolution Specifications: Failed 24 month dissolution testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0163-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-04 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
Product
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Reason
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Identifiers
| code_info | Lot # 1300939, Expiry: March 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2016%22
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