Compounding Risk Alerts

Report Adverse Events to FDA

Alerting Health Care Professionals of Compounding Risks

Serious patient illnesses and deaths have been linked to poor quality compounded drugs. The agency works to identify and mitigate risks through surveillance and complaint review, which includes adverse event and product quality reports.

The agency issues compounding risk alerts to inform health care professionals and compounders about risks associated with compounded drugs, including information on adverse events, outbreaks and issues with drug quality. These alerts are intended to help practitioners more effectively protect patients from unsafe, ineffective and poor-quality compounded medicines.

Compounding Risk Alerts

Date	Alert Description
July 26, 2024	FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products
June 5, 2024	FDA alerts health care professionals, compounders and patients of potential safety risks associated with sulfite-containing compounded drugs
May 21, 2024	Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors
October 10, 2023	FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders
February 16, 2022	FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray
October 25, 2021	FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions
February 4, 2021	FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products
August 12, 2020	FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin
June 7, 2019	FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables
March 12, 2019	Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
July 23, 2018	FDA alerts health care professionals of significant safety risks associated with cesium chloride
July 5, 2018	FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product
March 14, 2018	FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection
October 3, 2017	A case of hemorrhagic occlusive retinal vasculitis (HORV) following intraocular injections of a compounded triamcinolone, moxifloxacin, and vancomycin formulation
August 4, 2017	FDA investigates two serious adverse events associated with ImprimisRx’s compounded curcumin emulsion product for injection

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Report Adverse Events to FDA

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

Contact

Email: compounding@fda.hhs.gov