OII Recall Coordinators
FDA recall coordinators are aligned in program-based inspectorates: Medical Products (for Medical Devices and Radiological Health), Food Products (Human Food and Animal Food Operations (includes cosmetics)), Biological Products, Human and Animal Drugs and Tobacco Operations. Establishments outside the United States should continue to contact the recall staff in the Office of Field Operations and Response.
For new recalls, use the table below to locate the recall coordinator assigned for your product type and location. Drug and device firms located outside the United States should report their recall to the Recall Coordinator in the state where your U.S. Agent is located.
| Product Type | Division | Firm's State | Contact |
|---|---|---|---|
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | ME, NH, VT, NY, NJ, CT, RI, MA | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | PA, OH, KY, WV, VA, MD, DE | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | NC, SC, GA, FL, PR, US Virgin Islands | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | ND, SD, NE, KS, MN, IA, MO, IL, WI, IN, MI | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | WY, UT, CO, NM, AZ, TX, OK, AR, LA, MS, TN, AL | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Pharmaceutical | Human and Animal Drug Evaluation and Recall Branch | CA, NV, OR, AK, WA, ID, MT, HI, Guam, Northern Mariana Islands, American Samoa | Email: oiidrugrecalls@fda.hhs.gov Phone: 240-402-3874 |
| Medical Devices | Division of Medical Devices and Rad Health Inspectorate IV/Midwest | IA, IL, IN, KS, MI, MN, MO, MT, ND, NE, OH, SD, WI, WY | Email: oii-devices-midwest-recalls@fda.hhs.gov |
| Medical Devices | Division of Medical Devices and Rad Health Inspectorate III/Northeast | CT, DC, DE, KY, MA, MD, ME, NH, NJ, NY, PA, RI, VA, VT, WV | Email: oii-devices-northeast-recalls@fda.hhs.gov |
| Medical Devices | Division of Medical Devices and Rad Health Inspectorate II/South | AL, AR, FL, GA, LA, MS, NC, OK, PR, SC, TN, TX, Virgin Islands | Email: oii-devices-south-recalls@fda.hhs.gov |
| Medical Devices | Division of Medical Devices and Rad Health Inspectorate I/West | AK, AZ, CA, CO, HI, ID, NM, NV, OR, UT, WA, Guam, Northern Mariana Islands, American Samoa | Email: oii-devices-west-recalls@fda.hhs.gov |
| Biologics | Biologics Inspectorate | All U.S. | Thanh B. Tran Email: biologicsrecalls@fda.hhs.gov Phone: 949-608-3504 |
| Animal Foods | Animal Food Inspectorate | All U.S. | Nina Patel Email: oiioafianimalfoodrecalls@fda.hhs.gov Phone: 410-779-5132 |
| Tobacco | Tobacco Operations | All U.S. | LCDR Mouhamed Halwani Email: oiitobaccorecalls@fda.hhs.gov |
| Human Food | Human Food Inspectorate Central I | IL, IN, MI | Michael Larson Email: oiihfcentral1recalls@fda.hhs.gov Phone: 313-393-8118 |
| Human Food | Human Food Inspectorate Central II | AL, KY, LA, MS, OH, TN | Vacant Email: oiihfcentral2recalls@fda.hhs.gov |
| Human Food | Human Food Inspectorate Central III | MN, ND, SD, WI | Kristine Zuroski Email: oiihfcentral3recalls@fda.hhs.gov Phone: 612-758-7120 |
| Human Food | Human Food Inspectorate Central IV | AR, IA, KS, MO, NE, OK | Jeannie Vonderbrink, Acting Email: oiihfcentral4recalls@fda.hhs.gov Phone: 913-752-2193 |
| Human Food | Human Food Inspectorate Central V | TX | Brandi Williams Email: oiihfcentral5recalls@fda.hhs.gov Phone: 301-837-4769 |
| Human Food | Human Food Inspectorate East I | CT, MA, ME, NH, NY, RI, VT | Randi-Lynn Bodoh and Melissa Henaghan Email: oiihfeast1recalls@fda.hhs.gov Phone: 315-448-0876 ext. 1011 |
| Human Food | Human Food Inspectorate East II | DC, DE, MD, NJ, PA | Ruark Lanham Email: oiihfeast2recalls@fda.hhs.gov Phone: 215-717-3738 |
| Human Food | Human Food Inspectorate East III | GA, NC, SC, VA, WV | Emma Nesbit Email: oiihfeast3recalls@fda.hhs.gov Phone: 404-253-1224 |
| Human Food | Human Food Inspectorate East IV | FL, PR, US Virgin Islands | Beira Montalvo Email: oiihfeast4recalls@fda.hhs.gov Phone: 301-837-4617 |
| Human Food | Human Food Inspectorate West I | Southern CA (Zip codes covered: 90000-93199, 93400-93499, 93510, and 93532-93539) | Sparky Bartee Email: oiihfwest1recalls@fda.hhs.gov Phone: 619-941-3707 |
| Human Food | Human Food Inspectorate West II | Northern CA (All other zip codes) | Kacie Crowther Email: oiihfwest2recalls@fda.hhs.gov Phone: 301-837-4953 |
| Human Food | Human Food Inspectorate West III | AK, HI, ID, MT, OR, WA, Guam, Northern Mariana Islands, American Samoa | Anh Trinh Nguyen Email: oiihfwest3recalls@fda.hhs.gov Phone: 425-302-0467 |
| Human Food | Human Food Inspectorate West IV | AZ, CO, NM, NV, UT, WY | Mary Wall Email: oiihfwest4recalls@fda.hhs.gov Phone: 301-332-5434 |
OII Headquarters
For general recall inquiries, including guidance for foreign firms recalling products exported to the USA and FDA's 3rd party contract for Recall Audit Checks:
LCDR Mouhamed Halwani
Branch Chief
OII Office of Field Regulatory Operations (OFRO)
Field Recall Effectiveness Branch (FREB)
OIIRecalls@fda.hhs.gov
If a physical mailing address is required to transmit documents to OFRO FREB, please contact us at OIIRecalls@fda.hhs.gov.
If you encounter problems with a FDA-regulated products, the agency wants to know about them. Please direct concerns to the appropriate FDA center by visiting our SmartHub webpage, which will guide you to the appropriate webform or phone number.