Fenofibric Acid — Class III drug recall D-399-2014
Terminated recall by Mutual Pharmaceutical Company, Inc., reported 2014-01-15, distributed nationwide. Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect med
| Recall number | D-399-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mutual Pharmaceutical Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2014-01-06 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-04-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 53489-0677-07 |
| Lot numbers | 03/14, 6561703 |
Product
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
Reason for recall
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
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-399-2014. 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.