Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Fenofibric Acid Tablets Recalled by Tribute Pharmaceuticals US Inc. Due to Chemical Contamination: The product may contain trace amounts...

Date: October 1, 2015
Company: Tribute Pharmaceuticals US Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tribute Pharmaceuticals US Inc. directly.

Affected Products

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.

Quantity: 39,650 bottles

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tribute Pharmaceuticals US Inc.

Tribute Pharmaceuticals US Inc. has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report