FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics.  

Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections.  

Based on conditions observed by FDA and information provided by California regulatory authorities, FDA has concerns about the sterility of drugs distributed by Fullerton Wellness. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis.  

Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness, and not administer them. Patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional. 

FDA is not aware of any adverse reactions associated with the use of compounded drugs from Fullerton Wellness. However, compounders that are not registered with FDA as outsourcing facilities are primarily overseen by state regulators and are not required under federal law to report adverse events to FDA.  

Patients and health care professionals should report any adverse reactions to FDA’s MedWatch program: 

• Complete and submit the report online at www.fda.gov/medwatch/report.htm 

• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.