Radioactive Diagnostic Agent
Where is Fludeoxyglucose F-18 made?
27 companies sell it under their own name. Their labels name 52 factories in the United States.
United States 52
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| SOFIE Co. dba SOFIE20 mCi per 1 mL, 300 mCi per 1 mL · NDC 73410-003, 49609-101 | N-Molecular Inc. dba SOFIEMakes it | Oakwood Village, OH, United States | No problems foundJun 2025 |
| N-Molecular, Inc. dba SOFIEMakes it | Haverhill, MA, United States | Problems found, fixed voluntarilyNov 2024 | |
| N-Molecular, Inc. dba SOFIEMakes it | Colonie, NY, United States | No problems foundFeb 2026 | |
| SOFIE Co. dba SOFIEMakes it | Sanford, FL, United States | Problems found, fixed voluntarilyJan 2024 | |
| SOFIE Co. dba SOFIEMakes it | Romeoville, IL, United States | Problems found, fixed voluntarilyJul 2024 | |
| SOFIE Co. dba SOFIEMakes it | Sterling, VA, United States | Problems found, fixed voluntarilyJul 2025 | |
| SOFIE Co. dba SOFIEMakes it | Totowa, NJ, United States | Problems found, fixed voluntarilyAug 2023 | |
| SOFIE Co. dba SOFIEMakes it | Kansas City, MO, United States | Problems found, fixed voluntarilySep 2025 | |
| SOFIE Co. dba SOFIEMakes it | Gilroy, CA, United States | Problems found, fixed voluntarilyAug 2025 | |
| SOFIE Co. dba SOFIEMakes it | Morgantown, WV, United States | Problems found, fixed voluntarilyAug 2025 | |
| SOFIE Co. dba SOFIEMakes it | Dallas, TX, United States | Problems found, fixed voluntarilyApr 2026 | |
| SOFIE Co. dba SOFIEMakes it | Houston, TX, United States | Problems found, fixed voluntarilyOct 2025 | |
| SOFIE Co. dba SOFIEMakes it | Somerset, NJ, United States | Problems found, fixed voluntarilyJan 2023 | |
| SOFIE Co. dba SOFIEMakes it | Decatur, IL, United States | Problems found, fixed voluntarilyJan 2026 | |
| Precision Nuclear LLC500 mCi per 1 mL · NDC 52768-001 | Essential Isotopes, LLCMakes it | Columbia, MO, United States | Problems found, fixed voluntarilySep 2026 |
| Hot Shots Nm, LLCMakes it | Davenport, IA, United States | Problems found, fixed voluntarilyAug 2019 | |
| Pharmalogic Austin, LLCMakes it | Austin, TX, United States | Not inspected on record | |
| Pharmalogic Cincinatti, LLCMakes it | Cincinnati, OH, United States | No problems foundOct 2025 | |
| Pharmalogic Colorado, LLCMakes it | Aurora, CO, United States | No problems foundNov 2021 | |
| Pharmalogic New York City, LLCMakes it | Bronx, NY, United States | Serious problems, FDA actionAug 2026 | |
| Pharmalogic Puerto Rico, Inc.Makes it | San Juan, PR, United States | Problems found, fixed voluntarilyAug 2026 | |
| Pharmalogic Salt Lake City, LLCMakes it | Salt Lake City, UT, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Pharmalogic South Carolina, LLCMakes it | Duncan, SC, United States | No problems foundJul 2025 | |
| Precision Nuclear of Virginia, LLCMakes it | Salem, VA, United States | Problems found, fixed voluntarilyOct 2025 | |
| Precision Nuclear, LLCMakes it | Johnson City, TN, United States | No problems foundJul 2016 | |
| Wisconsin Medical Radiopharmacy, LLCMakes it | West Allis, WI, United States | No problems foundNov 2025 | |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma300 mCi per 1 mL · NDC 60055-334 | Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Norcross, GA, United States | No problems foundNov 2015 |
| Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Mobile, AL, United States | Problems found, fixed voluntarilyMar 2026 | |
| Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Macon, GA, United States | No problems foundDec 2018 | |
| Mayo Clinic240 mCi per 1 mL · NDC 52670-551 | Mayo Clinic PET Radiochemistry FacilityMakes it | Rochester, MN, United States | Problems found, fixed voluntarilySep 2025 |
| Mayo Clinic PET Radiochemistry FacilityMakes it | Phoenix, AZ, United States | Problems found, fixed voluntarilyJul 2026 | |
| Mayo Clinic PET Radiochemistry FacilityMakes it | Jacksonville, FL, United States | Problems found, fixed voluntarilyJul 2026 | |
| Biomedical Research Foundation of Northwest Louisiana300 mCi per 1 mL · NDC 24562-001, 24562-003 | Biomedical Research Foundation of Northwest LouisianaMakes it, tests it, packages it and labels it | Shreveport, LA, United States | Not inspected on record |
| Biomedical Research Foundation of Northwest LouisianaMakes it, tests it, packages it and labels it | Shreveport, LA, United States | Not inspected on record | |
| 3D Imaging Drug Design and Development LLC300 mCi per 1 mL · NDC 76451-118 | 3D Imaging Drug Design and DevelopmentMakes it | Little Rock, AR, United States | Serious problems, FDA actionJun 2025 |
| BAMF Health Inc.400 mCi per 1 mL · NDC 81759-001 | BAMF Health, Inc.Makes it | Grand Rapids, MI, United States | Not inspected on record |
| Barbara Ann Karmanos Cancer Hospital300 mCi per 1 mL · NDC 78714-001 | Barbara Ann Karmanos Cancer HospitalMakes it, tests it, packages it and labels it | Detroit, MI, United States | Problems found, fixed voluntarilySep 2025 |
| Brigham and Women's Hospital, Inc., The300 mCi per 1 mL · NDC 24450-647 | Brigham and Women`s Hospital, Inc., theMakes it | Boston, MA, United States | Problems found, fixed voluntarilyJun 2026 |
| Hamamatsu/Queen’s PET Imaging Center, LLC100 mCi per 1 mL · NDC 76376-618 | Hamamatsu/Queens PET Imaging Center, LLCMakes it | Honolulu, HI, United States | Problems found, fixed voluntarilyOct 2024 |
| Kettering Medical Center40 mCi per 1 mL · NDC 29998-001 | Kettering Medical CenterMakes it | Kettering, OH, United States | Problems found, fixed voluntarilyMay 2025 |
| Kreitchman PET Center100 mCi per 1 mL · NDC 62072-008 | Kreitchman PET CenterMakes it | New York, NY, United States | Problems found, fixed voluntarilyDec 2017 |
| MIPS Cyclotron & Radiochemistry Facility300 mCi per 1 mL · NDC 69587-001 | Molecular Imaging Program At StanfordMakes it | Palo Alto, CA, United States | Problems found, fixed voluntarilyOct 2024 |
| Massachusetts General Hospital300 mCi per 1 mL · NDC 76318-334 | Massachusetts General Hospital, TheMakes it | Boston, MA, United States | Not inspected on record |
| Northland Nuclear Medicine0.5 Ci per 1 mL · NDC 72634-001 | Northland Nuclear Medicine, LLCMakes it | Bismarck, ND, United States | Serious problems, FDA actionMay 2026 |
| The Methodist Hospital Research Institute0.3 Ci per 1 mL · NDC 69864-001 | The Methodist Hospital Research InstituteMakes it | Houston, TX, United States | Problems found, fixed voluntarilyFeb 2026 |
| The Regents of the University of Michigan300 mCi per 1 mL · NDC 76326-001 | Division of Nuclear Medicine PET Radiopharmaceutical Production ProgramMakes it | Ann Arbor, MI, United States | Serious problems, FDA actionSep 2025 |
| The University of Texas MD Anderson Cancer Center300 mCi per 1 mL · NDC 60215-411 | University of Texas MD Anderson Cancer CenterMakes it | Houston, TX, United States | Problems found, fixed voluntarilyFeb 2026 |
| The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute300 mCi per 1 mL · NDC 67939-010 | The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer InstituteMakes it | Salt Lake City, UT, United States | Problems found, fixed voluntarilySep 2024 |
| Trustees of the University of Pennsylvania200 mCi per 1 mL · NDC 40098-101 | Cyclotron Facility University of PennsylvaniaMakes it | Philadelphia, PA, United States | No problems foundSep 2025 |
| UCSF Radiopharmaceutical Facility300 mCi per 1 mL · NDC 24275-0185 | UCSF Radiopharmaceutical FacilityMakes it | San Francisco, CA, United States | Serious problems, FDA actionJul 2025 |
| UIHC – P E T Imaging Center300 mCi per 1 mL · NDC 24417-001 | UIHC-PET Imaging CenterMakes it | Iowa City, IA, United States | No problems foundSep 2026 |
| University of North Dakota500 mCi per 1 mL · NDC 24468-001 | University of North DakotaMakes it | Location not on file | Not inspected on record |
| Washington University School of Medicine300 mCi per 1 mL · NDC 75913-647 | Washington University, TheMakes it | Saint Louis, MO, United States | Problems found, fixed voluntarilyMar 2024 |
| Cardinal Health 414, LLC500 mCi per 1 mL · NDC 65857-150 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PETNET Solutions, Inc.200 mCi per 1 mL · NDC 40028-511 | The label doesn't name the factory. Plants this company names for other drugs | ||
| The Feinstein Institutes for Medical Research FludeoxyglucoseF18400 mCi per 1 mL · NDC 13267-234 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Feb 17, 2021 · Class II · The General Hospital Corporation
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.