Fenoglide — Class II drug recall D-0163-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2015-11-11, distributed nationwide. Failed Dissolution Specifications: Failed 24 month dissolution testing.
| Recall number | D-0163-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-09-04 |
| Classified | 2015-11-03 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-03-14 |
| Distributed | Nationwide (US) |
| Quantity | 3,341 bottles |
| Reason classes | specification failure |
| NDC | 68012-0495-90 |
| Lot numbers | 1300939 |
| Expiration dates | 2016-03-20 |
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 for recall
Failed Dissolution Specifications: Failed 24 month dissolution 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-0163-2016. 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.