Fenofibric Acid Tablets — Class III drug recall D-0016-2016
Terminated recall by Tribute Pharmaceuticals US Inc., reported 2015-10-21, distributed nationwide. Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnis
| Recall number | D-0016-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tribute Pharmaceuticals US Inc., Charlotte, NC, United States |
| Recall initiated | 2015-10-01 |
| Classified | 2015-10-14 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2017-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 39,650 bottles |
| Reason classes | chemical contamination, labeling |
| UPC / GTIN / UDI-DI | 00349708101078, 00353489677073 |
| NDC | 13310-0101-07, 49708-0101-07, 53489-0677-07 |
Product
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.
Reason for recall
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug 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-0016-2016. 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.