Fenofibric Acid Tablets 35mg (Tribute Pharmaceuticals) – chemical contamination (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 19
Brand
Tribute Pharmaceuticals US Inc.
Lot Codes / Batch Numbers
Lot #: a) 6631401, Exp 03/16, b) 6631403, Exp 03/16, 6697001, Exp 06/17, c) 6631402, Exp 03/16, 6663401, Exp 10/16, 6697002, 6697004, Exp 06/17
Products Sold
Lot #: a) 6631401, Exp 03/16; b) 6631403, Exp 03/16; 6697001, Exp 06/17; c) 6631402, Exp 03/16; 6663401, Exp 10/16; 6697002, 6697004, Exp 06/17
Tribute Pharmaceuticals US Inc. is recalling Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, due to Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026