Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an Incidents Program to identify and prevent outbreaks through surveillance of adverse events and product quality incidents. This effort has led to many actions by FDA including the issuance of compounding risk alerts to inform health care professionals, compounders and consumers about risks associated with compounded drugs, including information on adverse events, outbreaks or product quality. These are intended to alert stakeholders of the risks so that practitioners can more effectively protect patients from unsafe, ineffective and poor-quality compounded medicines.

Please contact compounding@fda.hhs.gov if you have any questions regarding the information provided in a compounding risk alert below:

• FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray (February 16, 2022)
• FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions (October 25, 2021)
• FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products (February 4, 2021)
• FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin (August 12, 2020)
• FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables (June 7, 2019)
• Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors (September 24, 2018)
• FDA alerts health care professionals of significant safety risks associated with cesium chloride (July 23, 2018)
• FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product (Update: July 5, 2018)
  • Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (Update: March 12, 2019)
• FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection (Updated: March 14, 2018)
• A case of hemorrhagic occlusive retinal vasculitis (HORV) following intraocular injections of a compounded triamcinolone, moxifloxacin, and vancomycin formulation (October 3, 2017)
• FDA investigates two serious adverse events associated with ImprimisRx’s compounded curcumin emulsion product for injection (August 4, 2017)

FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program: 

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178