Fenofibric Acid Tablets 105 mg — Class III drug recall D-0017-2016
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-0017-2016 |
|---|---|
| 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 | 140,607 bottles |
| Reason classes | chemical contamination, labeling |
| UPC / GTIN / UDI-DI | 00349708102075, 00349708102907, 00353489678070, 00353489678902 |
| NDC | 13310-0102-07, 13310-0102-90, 49708-0102-07, 49708-0102-90, 53489-0678-07, 53489-0678-87, 53489-0678-90 |
Product
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA.
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-0017-2016. 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.