Update: Primus Pharmaceuticals is recalling all unexpired lots of Limbrel products to the patient/consumer level at FDA’s request. Although Limbrel is currently marketed as a medical food, last month, FDA announced that the preliminary determination of our investigation is that Limbrel is an unapproved new drug: https://go.usa.gov/xn7xJ

PUBLIC HEALTH ALERT on LIMBREL: The FDA continues to receive and investigate reports of serious adverse events related to Limbrel and urges consumers who are taking this product to stop immediately. The agency has recommended that Primus Pharmaceuticals recall Limbrel. Read more about this investigation at: https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm585992.htm