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# FDA Urges Primus Pharma to Recall Suspect Product
- URL: https://www.fdaweb.com/fda-urges-primus-pharma-to-recall-suspect-product/
- Published: 2017-12-07T12:00:00.000Z
- Updated: 2026-09-14T23:06:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140287

FDA has asked Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The agency says the product is marketed as a medical food, but a preliminary determination suggests that Limbrel is an unapproved new drug.

A [safety alert](https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm586111.htm?ref=fdaweb.com) notes that so far the company has not acted on the agency’s request and it does not have mandatory recall authority over drug products. The alert warns that Limbrel should not be used because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis.

FDA says it has been investigating serious adverse events involving Limbrel. It has received 194 adverse event reports involving the product. Of these, 30 contained “sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists,” it says.