CLASS III Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Fenofibric Acid Tablets, 35 mg, labeled as a) Fibricor recalled
Tribute Pharmaceuticals US is recalling Fenofibric Acid Tablets, 35 mg, labeled as a) Fibricor (fenofibric acid) Tablets, distributed nationwide in the US. The recall was initiated on 1 Oct 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0016-2016
- FDA event ID
- 72346
- Recalling firm
- Tribute Pharmaceuticals US, Charlotte, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Oct 2015
- FDA classified
- 14 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
Timeline
| 1 Oct 2015 | Recall initiated by company | |
| 14 Oct 2015 | Classified by FDA | +13 days |
| 21 Oct 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72346This product is part of a recall event; the main page for the event is Fenofibric Acid Tablets 105 mg recalled by Tribute Pharmaceuticals US.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Fenofibric Acid Tablets 105 mg recalled by Tribute Pharmaceuticals US | Tribute Pharmaceuticals US | Other | Nationwide |
More recalls from Tribute Pharmaceuticals US
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibric Acid Tablets 105 mg recalled by Tribute Pharmaceuticals US | Tribute Pharmaceuticals US | Other | Nationwide |
Other Fenofibric Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibric Acid Tablets 105 mg recalled by Tribute Pharmaceuticals US | Tribute Pharmaceuticals US | Other | Nationwide |
| Drug | CLASS III | Fenofibric Acid, immediate release tablet, 35 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fenofibric Acid, immediate release tablet, 105 mg, a) bottle recalled | Mutual Pharmaceutical | Other | Nationwide |