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 |
| April 22, 2025 |
FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products |
| 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 |
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
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Content current as of:
04/22/2025
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