Fibricor 105mg Recall: Benzophenone Contamination Risk
Tribute Pharmaceuticals recalls Fibricor tablets due to benzophenone contamination. Check your NDC and lot numbers for affected batches.
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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.
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What happened, in plain English
Tribute Pharmaceuticals US Inc. is recalling specific lots of Fenofibric Acid Tablets 105 mg, marketed under the brand name Fibricor. The recall is necessary because trace amounts of benzophenone, a component of the label varnish, may have leached through the bottle and contaminated the drug product. This chemical contamination poses a potential health risk to consumers taking this prescription medication. Read more at govinfonow.com/recall/43605-tribute-pharmaceuticals-us-inc-recalls-fenofibric-acid-tablets-105-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43605-tribute-pharmaceuticals-us-inc-recalls-fenofibric-acid-tablets-105-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0017-2016
Cite this page
“Fibricor 105mg Recall: Benzophenone Contamination Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43605-tribute-pharmaceuticals-us-inc-recalls-fenofibric-acid-tablets-105-mg. Based on FDA recall #D-0017-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0017-2016%22&limit=1).
Why it’s dangerous
The label varnish on the bottle contains benzophenone, which can migrate through the plastic container into the tablets. Ingesting medication contaminated with this chemical component presents an unknown health hazard, as it is not intended to be part of the drug product.
Who’s affected
Individuals who have been prescribed Fenofibric Acid Tablets 105 mg (Fibricor) and possess bottles with the specific NDC, UPC, and lot numbers listed in the record. This includes patients in the United States and Puerto Rico who purchased these medications nationwide.
How to tell if you have this one
Check your prescription bottles for NDC numbers 13310-102-07, 13310-102-90, 49708-102-07, 49708-102-90, 53489-678-07, or 53489-678-90. Verify the lot numbers (such as 6623102, 6674403, 6623001, etc.) and expiration dates (01/16, 01/17, 04/16, or 05/17) against the record. The bottles are 30-count or 90-count sizes labeled as Fibricor or Fenofibric Acid Tablets.
- Brand
Fibricor- Product
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0016-2016 | 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.; 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 | 39,650 bottles |
| D-0017-2016 | 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.; Lot numbers: a) 6623102, Exp 01/16; b) 6623104, Exp 01/16; c) 6674403, Exp 01/17; d) 6674402, Exp 01/17; e) 6623001, 6623004, 6623103, Exp 01/16; 6639202, 6639203, 6639303, 6639304, Exp 04/16; 6674404, Exp 01/17; 6693301, Exp 05/17; f) 6623002, 6623005, 6623105, Exp 01/16; 6639301, 6639305, Exp 04/16; 6674401, Exp 01/17; 6693302, Exp 05/17; g) 6623003, 6623106, Exp 01/16; 6639201, Exp 04/16. | 140,607 bottles |
What to do — step by step
Stop taking the medication
Do not consume any tablets from the recalled lots due to potential benzophenone contamination.
Contact your pharmacist or doctor
Speak with your healthcare provider or pharmacist immediately to discuss alternative treatment options and how to dispose of the recalled product safely.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which specific lot numbers are affected by this recall?
Affected lots include 6623102, 6623104, 6674403, 6674402, 6623001, 6623004, 6623103, 6639202, 6639203, 6639303, 6639304, 6674404, 6693301, 6623002, 6623005, 6623105, 6639301, 6639305, 6674401, 6693302, 6623003, 6623106, and 6639201.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0017-2016 (October 1, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0017-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.