Recent FDA warning letters
Last checked Oct 16, 2026.
| Company | Letter date | FDA subject |
|---|---|---|
| Eurofins SF Analytical Laboratories, Inc. | Oct 6, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Lewis Sausage Company Inc. | Aug 5, 2026 | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Ocean Pride Seafood, Inc. | Sep 11, 2026 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| originalc.co.uk | Oct 2, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Hanlim Pharm Co., Ltd. | Oct 2, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Jiangmen Shuizirun Sanitary Articles Co., Ltd. | Sep 23, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| RDM Express Inc. | Sep 11, 2026 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Moda Food LLC | Sep 9, 2026 | Foreign Supplier Verification Program (FSVP) |
| Ruukoo International Food Market Inc. | Jul 22, 2026 | Foreign Supplier Verification Program (FSVP) |
| Datil Fresh Produce LLC | Sep 22, 2026 | Foreign Supplier Verification Program (FSVP) |
| Distribuidora Jazmin LLC | Aug 13, 2026 | Foreign Supplier Verification Program (FSVP) |
| Dreyer’s Grand Ice Cream, Inc. | Sep 29, 2026 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| SCA Pharmaceuticals, LLC | Sep 14, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Unilam Co., LTD | Sep 22, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| DesBio/Deseret Biologicals, Inc. | Oct 1, 2026 | Unapproved New Drugs |
| Aidance Scientific, Inc. | Oct 1, 2026 | Unapproved New Drugs |
| The Platinum Healthcare LLC | Oct 1, 2026 | Unapproved New Drugs |
| Graceful Touch, LLC | Oct 1, 2026 | Unapproved New Drugs |
| Amazon.com, Inc. | Oct 1, 2026 | Unapproved New Drugs |
| OrganiCare, LLC / OrganiCare Nature’s Science, LLC | Oct 1, 2026 | Unapproved New Drugs |
| Bioactive Services USA, LLC / Herstat Inc. | Oct 1, 2026 | Unapproved New Drugs |
| RoyceDerm LLC | Oct 1, 2026 | Unapproved New Drugs |
| Pine Pharmaceuticals, LLC | Aug 7, 2026 | Compounding Pharmacy/Adulterated Drug Products |
| TCI Co., Ltd BioCosme PABP BRANCH | Sep 2, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| O.N. Diagnostics, LLC | Sep 1, 2026 | Medical Device Reporting/Misbranded |
| Tipical Latin Food, Corp. DBA La Pradera | Aug 28, 2026 | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
| Walmart, Inc. | Oct 1, 2026 | Unapproved New Drugs |
| Online Generic Medicine/www.onlinegenericmedicine.com | Sep 23, 2026 | Unapproved New Drug/Misbranded (Internet Pharmacy) |
| Cheap Medicine Shop/www.cheapmedicineshop.com | Sep 24, 2026 | Unapproved New Drugs/Misbranded (Internet Pharmacy) |
| Importaciones La Bufa LLC | Aug 17, 2026 | Foreign Supplier Verification Program (FSVP) |
| Star Ocean Wholesale Foods, Inc. | Sep 1, 2026 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Sciarra Aeromed, Inc. | Sep 23, 2026 | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Neogen Corporation | Sep 23, 2026 | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Stream2Sea, LLC | Feb 2, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Bentley Laboratories LLC | Sep 17, 2026 | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Wellmill, LLC dba Vitamix Laboratories | Apr 20, 2026 | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Babikian Healthcare Products CJSC | Sep 21, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Stokes Healthcare Inc. dba Epicur Pharma | Aug 4, 2026 | Animal Drugs/Adulterated |
| American Pharma Mfg. Inc. | Aug 4, 2026 | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Fil-Bay Import, Inc. | Jul 20, 2026 | Foreign Supplier Verification Program (FSVP) |
| Bo Wah Enterprises Inc | Aug 13, 2026 | Foreign Supplier Verification Program (FSVP) |
| VeganicSKN Limited | Feb 9, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| South Asian Food Inc. | Aug 20, 2026 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Andrighetto Produce Inc dba Shasta Produce Inc | Aug 27, 2026 | Foreign Supplier Verification Program (FSVP) |
| sfshoply.com | Sep 25, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Kellin Chemicals Co., Ltd. - Zhangjiagang | Nov 6, 2025 | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Curia New York, Inc. | Sep 18, 2026 | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Fresenius Kabi USA LLC | Sep 22, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| kdc/one Chatsworth, Inc. | Sep 8, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| NexCell Scientific Inc | Sep 11, 2026 | Unapproved New Drugs/Unlicensed Biological Product Violations |
| Raaw Energy LLC | Aug 21, 2026 | Adulterated Animal Foods/Misbranded |
| Union Trade Inc. | Aug 27, 2026 | Foreign Supplier Verification Program (FSVP) |
| Quantum Star LLC | Aug 5, 2026 | Foreign Supplier Verification Program (FSVP) |
| Viva Raw LLC | Aug 5, 2026 | Adulterated Animal Foods/Misbranded |
| Shouly Import Corp. | Jun 26, 2026 | Foreign Supplier Verification Program (FSVP) |
| Ohom Padmaavathii, LLC | Jul 22, 2026 | Foreign Supplier Verification Program (FSVP) |
| BioDrive, Inc. | Aug 24, 2026 | Dietary Supplement/Adulterated |
| Lion Street Medical, d/b/a Pensar Medical LLC | Aug 21, 2026 | Medical Device Reporting/Misbranded |
| Specialty Health Products CO, LLC | Jul 7, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Advance-Esthetic LLC | Aug 25, 2026 | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Empower Clinic Services, LLC dba Empower Pharmacy | Sep 18, 2026 | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| LDNN Produce Inc. | Jul 15, 2026 | Foreign Supplier Verification Program (FSVP) |
| Yam Man Foods LLC | Jun 1, 2026 | Foreign Supplier Verification Program (FSVP) |
| H2 BEV, LLC and H2 RENU, INC | Jul 31, 2026 | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded |
| Happy Farm Botanicals, Inc. | Sep 1, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Reliance Life Sciences Private Limited | Aug 18, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Jabil Inc. | Aug 27, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Shoolin Pharma Chem LLP | Aug 18, 2026 | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| TXP Innovations LLC dba Tex Peptides | Aug 24, 2026 | Unapproved New Drugs/Misbranded |
| Mesquite Gourmet LLC | Aug 4, 2026 | Foreign Supplier Verification Program (FSVP) |
| Royal Peptides LLC | Aug 24, 2026 | Unapproved New Drugs/Misbranded |
| NuScience Peptides LLC | Aug 24, 2026 | Unapproved New Drugs/Misbranded |
| Peptide Partners LLC | Aug 24, 2026 | Unapproved New Drugs/Misbranded |
| Fresenius Medical Care AG & Co. KGaA | Aug 25, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| PReye, LLC | Aug 18, 2026 | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| B&P Mutual Corp | Aug 18, 2026 | Foreign Supplier Verification Program (FSVP) |
| Vargas Produce LLC | Jul 27, 2026 | Foreign Supplier Verification Program (FSVP) |
| R3 Medical Companies | Aug 14, 2026 | Unapproved New Drugs/Unlicensed Biological Product Violations |
| Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. | Aug 6, 2026 | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded |
| Nipro Renal Solutions USA, Corporation | Jul 24, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| K.C. Pharmaceuticals, Inc. | Aug 12, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Suretec Innovations, LLC | Aug 13, 2026 | CGMP/Finished Pharmaceuticals/Adulterated and Misbranded |
| Eugia Pharma Specialities Limited | Aug 13, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Auriga Research Pvt. Ltd. | Aug 12, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Safrel Pharmaceuticals LLC | Aug 7, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| mikuvape.com | Aug 7, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| DeJong Family Dairy, LLC | Jul 30, 2026 | New Animal Drug/Adulterated |
| Waves and Wine, Inc. | Jul 6, 2026 | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated |
| giantnic.com | Aug 7, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| FairyGene, Inc. | Jul 31, 2026 | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Lico Industries, LLC., d.b.a. American Towelette Company | Jul 30, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Tex-Stein Dairy | Jun 16, 2026 | New Animal Drug/Adulterated |
| Dabur India Limited | Jul 24, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| ABS Corporation | Jul 23, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Koven Technologies, Inc. | Jul 21, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| AAL Trading Inc. | Jul 15, 2026 | Foreign Supplier Verification Program (FSVP) |
| Friend’s Stable and Orchard, Inc. | Jul 14, 2026 | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
| Woodbine Products Company Inc. | Jul 27, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Thomas Brunner Hygiene GmbH | Jul 24, 2026 | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Delight Distribution Inc. | Jun 8, 2026 | Foreign Supplier Verification Program (FSVP) |
| Piquin Y Sabores Distributors LLC | Jul 2, 2026 | Foreign Supplier Verification Program (FSVP) |
| San Jorge Produce LLC | Jul 16, 2026 | Foreign Supplier Verification Program (FSVP) |
| Prida Import & Export LLC | Apr 10, 2026 | Foreign Supplier Verification Program (FSVP) |
| AHC Products, Inc. | Jun 12, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| VasoCorp, Inc. | Jul 9, 2026 | Unapproved New Drugs/Misbranded |
| Eherbs Imports, Inc | Jul 23, 2026 | Foreign Supplier Verification Program (FSVP) |
| Linemaster Switch Corporation | May 27, 2026 | CGMP/QSR/Drug/Medical Devices/Adulterated |
| Mineral BioSciences, LLC | Jun 5, 2026 | Unapproved New Drugs/Misbranded |
| ejuicedemand.com | Jul 10, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| indejuicevapestore.co.uk | Jul 10, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Island Kinetics, Inc. d.b.a. CoValence Laboratories | Jul 16, 2026 | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| BioMylz Pvt. Ltd. | Jul 13, 2026 | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Almon Healthcare Private Limited | Jul 13, 2026 | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Shang Hao Jia, Inc. | Mar 18, 2026 | Foreign Supplier Verification Program (FSVP) |
| Balkanica LLC | Jun 29, 2026 | Foreign Supplier Verification Program (FSVP) |
| Beauty Store LLC | Jul 8, 2026 | Foreign Supplier Verification Program (FSVP) |
| IJAJ Group Inc DBA Sanz Wholesale Foods | Jul 8, 2026 | Foreign Supplier Verification Program (FSVP) |
| mkpodplug.co.uk | Jul 17, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| ZIIP, Inc. | May 22, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Spa De Soleil, Inc. | Jul 8, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| International Medication Systems Limited | Jul 2, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Win Woo Trading, LLC / HF Foods Group | Jun 24, 2026 | Foreign Supplier Verification Program (FSVP) |
| Allandale Dairy | Jun 23, 2026 | New Animal Drug/Adulterated |
| snusblast.co.uk | Jul 2, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Nutratech, LLC | Jun 4, 2026 | CGMP/Dietary Supplement/Adulterated/Misbranded |
| eliquidflavourconcentrates.co.uk | Jul 2, 2026 | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Full Fresh Produce LLC | Apr 10, 2026 | Foreign Supplier Verification Program (FSVP) |
| Nihon Kohden Digital Health Solutions, LLC | Jun 12, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| AF Import & Wholesale Co | May 26, 2026 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Diamond Distributions LLC | Jun 16, 2026 | Foreign Supplier Verification Program (FSVP) |
| LyfeUnit / www.lyfeunit.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| BlephEx, LLC | Jun 3, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Buy Keta Online / www.buyketaonline.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Skytron, LLC | May 19, 2026 | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| ketaminetroches.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Bushman Organic Farms, Inc. | May 14, 2026 | Foreign Supplier Verification Program (FSVP) |
| All Ketamine HCL / www.allketaminehcl.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Med Shop Inc / www.medshopinc.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Ketamine Troche Store / www.ketaminetrochestore.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Ketamine Store / www.ketaminestore.org | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Legit Ketamine Suppliers / www.legitketaminesuppliers.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Ketacyn Pharmaceuticals / www.ketacynpharma.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Keta Med Lab / www.ketamedlab.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Extra Medication / www.extramedication.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Ketdaxandrugs / www.ketdaxandrugs.org | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| Ket Plug / ketaminelab.org and buyketaminepowderonline.com | Jun 23, 2026 | Unapproved New Drugs/Misbranded |
| 3B Medical, Inc. dba Reach Health, Inc. | May 20, 2026 | CGMP/QSR/Medical Devices/Adulterated |
| Yangzhou Hongshengding Chemical Co., Ltd. | Jun 15, 2026 | Refusal to Provide Access to and Copying of Records |
| Wizcure Pharmaa Private Limited | Jun 24, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| BMC Medical Co., Ltd. | May 20, 2026 | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Genzyme Ireland Limited | Jun 22, 2026 | CGMP/Deviations/Biologics License Application (BLA) |
| Golden Dakota Farms LLC | May 20, 2026 | New Animal Drug/Adulterated |
| AseptiKits, LLC | Jun 4, 2026 | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Huons Co., Ltd. | Jun 15, 2026 | CGMP/Finished Pharmaceuticals/Adulterated |
| Imu-Tek Animal Health, Incorporated | Jun 5, 2026 | Dietary Supplement/New Drug/Misbranded |
| Vivot LLC | Jun 8, 2026 | Foreign Supplier Verification Program (FSVP) |
| Pamex Foods Incorporated | May 26, 2026 | Foreign Supplier Verification Program (FSVP) |
| Great Enterprise - Group - Inc. | Apr 17, 2026 | Foreign Supplier Verification Program (FSVP) |
| Global Imports Origins | Apr 23, 2026 | Foreign Supplier Verification Program (FSVP) |