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Posted January 30, 2018

Limbrel for Osteoarthritis Recalled Due to Risk of Adverse Effects

On January 26, 2018, Primus Pharmaceuticals, Inc. of Scottsdale, Arizona issued a recall of all unexpired lots of Limbrel products. FDA  requested the recall due to rare but serious side effects (which are reversible), including drug-induced liver injury and/or hypersensitivity pneumonitis, associated with the use of Limbrel

Limbrel is available by prescription only and is marketed as a medical food to "meet the distinctive nutritional requirements of patients with osteoarthritis." It contains flavocoxid, described on the company's website as a "a proprietary blend of natural ingredients from phytochemical food source materials." The label states that it contains the flavonoids (plant compounds) baicalin (from Scutellaria baicalensis, also known as Chinese skullcap) and catechin (from Acacia catechu). Some capsules also contain zinc.

(In December 2017, the FDA warned consumers of the risks associated with Limbrel.) 

Recalled Limbrel products are available by prescription only and have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians, and can be identified by the following:


  • Limbrel (flavocoxid) 250 mg capsules, Product Identity Number: 68040-601-16


  • Limbrel 250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number: 68040-605-16


  • Limbrel (flavocoxid) 500 mg capsules, Product Identity Number: 68040-602-16


  • Limbrel 500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number: 68040-606-16


Consumers who have unopened product should stop use and go to www.limbrel.com for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, and can report any adverse reactions to the FDA's MedWatch Adverse Event Reporting Program.

See ConsumerLab.com's  Glucosamine, Chondroitin, MSM and Boswellia Supplements for Joint Health for tests of products promoted for joint health or joint pain.

See related recalls and warnings:

Limbrel Capsules for Osteoarthritis Linked With Potentially Life-Threatening Health Risk, FDA Warns

To read the complete recall notice, use the link below.