ORA Recall Coordinators
FDA recall coordinators are aligned in program-based divisions: Division of Medical Devices and Radiological Health, Division of Human and Animal Food Operations (includes cosmetics), Division of Biological Products, Division of Pharmaceutical Quality Operations and Tobacco Operations. Establishments outside the United States should continue to contact the recall branch in the Office of Strategic Planning and Operational Policy.
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 | Recall Coordinator | Address | Phone/Fax | |
---|---|---|---|---|---|---|
Biologics | Division of Biological Products Operations I | All U.S.
AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;
|
Thanh B Tran | 19701 Fairchild Irvine, CA 92612 |
Phone: 949-608-3504 Fax: 949-608-4401 |
biologicsrecalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East I | CT; MA; ME; NH; NY; RI; VT | Melissa A. Henaghan | Albany Resident Post One Winners Circle, Suite 110 Albany NY 12205 |
Phone: 518-453-2314 x 1017 Fax: 518-453-2443 |
orahafeast1recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East I | CT; MA; ME; NH; NY; RI; VT | Randi-Lynn Bodoh | Syracuse Resident Post 620 Erie Blvd., West Syracuse, NY 13205 |
Phone: 315-448-0876 x 1011 Fax: 518-453-2443 |
orahafeast1recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East II | DC; DE; MD; NJ; PA; VA; WV | Ruark Lanham | 900 US Customhouse, Suite 904 200 Chestnut Street Philadelphia, PA 19106 |
Phone: 215-717-3738 Fax: 215-517-6649 |
orahafeast2recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East II | DC; DE; MD; NJ; PA; VA; WV | Nina Patel | 6000 Metro Drive, Suite 101 Baltimore, MD 21215 | Phone: 410-779-5132 | orahafeast2recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East III | GA; NC; SC | Emma Nesbit | 60 Eighth Street, NE Atlanta, GA 30309 |
Phone: 404-253-1224 Fax: 404-253-1201 |
orahafeast3recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East IV | FL; PR; US Virgin Islands | VACANT | 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 |
Phone: 787-729-8709 Fax: 787-729-8826 |
orahafeast4recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East V | AL; KY; LA; MS; OH; TN | Caitlin Almonrode | 404 BNA Drive, Suite 500 Nashville, TN 37217 | Phone: 615-366-7859 | orahafeast5recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations East VI | IL; IN; MI | Michael Larson | 300 River Place, Suite 5900 Detroit, MI 48207 |
Phone: 313-393-8118 Fax: 313-393-8139 |
orahafeast6recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West I | MN; ND; SD; WI | Kristine Zuroski | 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 |
Phone: 612-758-7120 Fax: 612-334-4134 |
orahafwest1recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West II | IA; KS; MO; NE | Shannon Hall | 8050 Marshall Drive Suite 205 Lenexa, KS 66214 |
Phone: 913-495-5160 Fax: 913-495-5105 |
orahafwest2recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West III | AR; OK; TX | Brandi Williams | 4040 N. Central Expressway Suite 300 Dallas, TX 75204 |
Phone: 501-324-5257 ext. 103 Fax: 501-324-5080 |
orahafwest3recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West IV | AZ; CO; NM; UT; WY | Jamie Port | Building 20, Denver Federal Center 6th Avenue & Kipling Street PO Box 25087 Denver, CO 80225-0087 |
Phone: 808-404-4628 Fax: 303-236-3551 |
orahafwest4recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West V | CA; HI; NV | VACANT | 1201 Harbor Bay Parkway Alameda, CA 94502 |
Phone: 510-337-6898 Fax: 510-337-6705 |
orahafwest5recalls@fda.hhs.gov |
Human and Animal Food & Cosmetics | Division of Human and Animal Food Operations West VI | AK; ID; MT; OR; WA | Anh Trinh Nguyen | 22215 26th Ave. SE, Suite 210 Bothell, WA 98021 |
Phone: 425-302-0467 Fax: 425-302-0403 |
orahafwest6recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations I | CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV | Andrew Lang | 6751 Steger Drive Cincinnati, OH 45237 |
Phone: 513-679-2700 x2177 Fax: 513-679-2773 |
oradevices1recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations I | CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV | Emma Schaefer | 101 W. Broad St. Suite 400 Falls Church, VA 22046 | Phone: 813-915-7968 | oradevices1recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations I | CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV | Cynthia Aycock | 300 River Place Dr. Ste. 5900 Detroit, MI 48207 |
Phone: 313-393-8162 Fax: 313-393-8139 |
oradevices1recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations I | CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV | VACANT | 555 Winderley Place Suite 200 Maitland, FL 32751 |
Phone: 407-475-4735 Fax: 407-475-4769 |
oradevices1recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations II | AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; PR; SC; SD; TN; US Virgin Islands; WI | Meredith Andress | 4121 Carmichael Rd Suite 307 Montgomery, AL 36106 |
Phone: 334-273-4788 ext. 106 Fax: 334-273-4790 |
oradevices2recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations II | AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; PR; SC; SD; TN; US Virgin Islands; WI | Marie Fink | US FDA Metairie Center 2424 Edenborn Avenue, Suite 410 Metairie, LA 70001 |
Phone: 504-846-6109 Fax: 504-219-8813 |
oradevices2recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations III | AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY | Mark Chan | 96 North Third Street, Room 420 San Jose, CA 95112 |
Phone: 408-291-7548 x 1108 Fax: 408-291-7228 |
oradevices3recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations III | AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY | Theresa Kirkham | 19701 Fairchild Irvine, CA 92612 |
Phone: 949-608-4437 Fax: 949-608-4498 |
oradevices3recalls@fda.hhs.gov |
Medical Device | Division of Medical Device and Radiological Health Operations III | AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY | Paul Frazier | 4040 N. Central Expressway, Suite 300 Dallas, TX 75204 |
Phone: 214-253-5340 Fax: 214-253-5314 |
oradevices3recalls@fda.hhs.gov |
Pharmaceutical | Division of Pharmaceutical Quality Operations I | CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV | Lisa Mathew | 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 |
Phone: 973-331-4917 Fax: 973-331-4969 |
orapharm1recalls@fda.hhs.gov |
Pharmaceutical | Division of Pharmaceutical Quality Operations I | CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV | Dellarese Priester | 60 8th Street NE Suite 102 Atlanta, GA 30309 | Phone: 215-717-3747 | orapharm1recalls@fda.hhs.gov |
Pharmaceutical | Division of Pharmaceutical Quality Operations II | AL; AR; FL; GA; LA; MS; NC; OK; PR; SC; TN; TX; US Virgin Islands | VACANT | 501 West Felix Street Suite 1103 Fort Worth, TX 76115 |
Phone: 817-334-5218 Ext. 1104 Fax: 817-334-5642 |
orapharm2recalls@fda.hhs.gov |
Pharmaceutical | Division of Pharmaceutical Quality Operations III | IA; IL; IN; KY; KS; MI; MN; MO; ND; NE; OH; SD; WI | Mennie Thompson | 550 West Jackson Blvd., #1625 Chicago, IL 60661 |
Phone: 312-596-4239 Fax: 312-596-4125 |
orapharm3recalls@fda.hhs.gov |
Pharmaceutical | Division of Pharmaceutical Quality Operations IV | AK; AZ; CA; CO; HI; ID; MT; NM; NV; OR; UT; WA; WY | Farhana Khan | 22215 26th Ave. SE Suite 210 Bothell, WA 98021 | Phone: 425-302-0361 | orapharm4recalls@fda.hhs.gov |
Tobacco | Tobacco Operations | All U.S.
AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;
|
LCDR Mouhamed Halwani | WO 32 RM 4352 10903 New Hampshire Ave. Silver Spring, MD 20993 | oratobaccorecalls@fda.hhs.gov |
ORA 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
ORA Office of Policy Compliance & Enforcement
Recall Operations Branch (OPCE ROB)
orarecalloe@fda.hhs.gov
If a physical mailing address is required to transmit documents to OPCE ROB, please contact us at orarecalloe@fda.hhs.gov.