FDA posted 87 warning letters in June 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 62; Office of Inspections and Investigations 11; Human Foods Program 6; Center for Devices and Radiological Health 5; Center for Biologics Evaluation and Research (CBER) 2; and others. Each row gives the agency's own subject line and links to the letter.
| Posted | Letter date | Company | Issuing office | Subject (FDA's words) | Letter |
|---|---|---|---|---|---|
| 2026-06-30 | 2026-05-20 | 3B Medical, Inc. dba Reach Health, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-06-30 | 2026-06-04 | AseptiKits, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Read the letter |
| 2026-06-30 | 2026-05-20 | BMC Medical Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | Read the letter |
| 2026-06-30 | 2026-06-25 | Excelvision - Fareva | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-30 | 2026-05-12 | Flax & More Corporation | Human Foods Program | CGMP/Dietary Supplement/Adulterated | Read the letter |
| 2026-06-30 | 2026-06-22 | Genzyme Ireland Limited | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) | Read the letter |
| 2026-06-30 | 2026-05-20 | Golden Dakota Farms LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated | Read the letter |
| 2026-06-30 | 2026-06-15 | Life & Food Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-30 | 2026-06-24 | Wizcure Pharmaa Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-30 | 2026-06-15 | Yangzhou Hongshengding Chemical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records | Read the letter |
| 2026-06-23 | 2026-06-17 | Amazon.com, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-04-23 | Global Imports Origins | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-23 | 2026-04-17 | Great Enterprise - Group - Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-23 | 2026-06-17 | Great India Overseas Pvt. Ltd. dba Silkrute | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | Read the letter |
| 2026-06-23 | 2026-06-17 | Hadassah Healing Oils Ltd | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | Read the letter |
| 2026-06-23 | 2026-06-17 | Herbal Dermals LLC FZ dba Gotucream | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-15 | Huons Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-23 | 2026-06-05 | Imu-Tek Animal Health, Incorporated | Human Foods Program | Dietary Supplement/New Drug/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-17 | Indiangoods.shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-17 | JJLBRO | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-05-28 | Jubilant HollisterStier General Partnership | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-23 | 2026-06-17 | Leading Edge Health Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-17 | MantroForce | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-05-26 | Pamex Foods Incorporated | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-23 | 2026-06-17 | Telos Trading Limited dba Alwinshop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-17 | Texinkart Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-08 | Vivot LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-23 | 2026-06-17 | Wholesale Peptide | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-23 | 2026-06-17 | Wild Arabic Herbs | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-06-16 | 2026-06-08 | Altru Telehealth, LLC dba Altru Telehealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Amie Health, Inc. dba Amie | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Clover Meds LLC dba Clover Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | D&H Medical Services | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Eden Health International Inc. dba Eden | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Ezra Holdco LLC dba Ezra | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | FITISH | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | FitRX, LLC dba AM RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Glow Medispa, LLC dba Mint Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | HydraMed IV LLC dba HydraMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-03 | InvaDerm, Inc. | Center for Drug Evaluation and Research (CDER) | Electronic Drug Registration and Listing System (eDRLS)/Violations | Read the letter |
| 2026-06-16 | 2026-06-08 | Joi and Blokes dba Joi + Blokes | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-02 | M G R Produce LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-16 | 2026-06-08 | Maximus Health, Inc. dba Maximus | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Medica Weight Loss | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Momentum Health 360 dba Momentum Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | NativeMed LLC dba NativeMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Nexlife Inc. dba Nexlife | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Nexus Health Solutions LLC dba Harper Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Nova Vascular LLC dba NOVARX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | OrderlyMeds LLC dba OrderlyMeds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-05-27 | Pharmathen International S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-06-16 | 2026-06-08 | Public Health Solution LLC dba DrMedHealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Ready Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Roen Health, Inc. dba RoenRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-05 | Sante Manufacturing Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-16 | 2026-06-02 | SL Follen Company | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-16 | 2026-06-08 | Thrivelab Co. dba Thrivelab | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | Trinity HealthCare Supply, LLC dba altRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | VivioMD Group LLC dba VivioMD | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | Read the letter |
| 2026-06-16 | 2026-06-08 | YS Group Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-16 | 2026-04-30 | ZOLL Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-06-15 | 2026-06-15 | Happiest Baby, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Read the letter |
| 2026-06-09 | 2026-06-02 | Asanuma Corporation - Sagamihara Factory | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-05-14 | Bharat Overseas Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-09 | 2026-06-02 | Erkul Kozmetik Sanayi ve Ticaret A.S. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-05-12 | Fagron BV | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | Read the letter |
| 2026-06-09 | 2026-06-02 | Gopaldas Visram & Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-06-03 | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-06-09 | 2026-05-28 | Jose M. Carpio, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | Read the letter |
| 2026-06-09 | 2026-06-02 | Laboratorios Dr. Collado S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-05-29 | Macau-Union Pharmaceutical Limited | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC | Read the letter |
| 2026-06-09 | 2026-06-02 | PLZ Corp | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-06-02 | Revlon Group Holdings, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-06-02 | Shantou Qiwei Industry Co., LTD | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-06-02 | Umendra Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-09 | 2026-06-02 | Zydus Lifesciences Limited | Center for Drug Evaluation and Research (CDER) | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-02 | 2026-05-22 | Aeroflex Industria de Aerosol Ltda. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records | Read the letter |
| 2026-06-02 | 2026-05-20 | Aversa's Italian Bakery | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Read the letter |
| 2026-06-02 | 2026-05-26 | Blue Horizon International, LLC | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations | Read the letter |
| 2026-06-02 | 2026-04-22 | Boba Factory Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-06-02 | 2026-05-15 | City Market, Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Read the letter |
| 2026-06-02 | 2026-05-12 | Dough-To-Go, Inc. | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Read the letter |
| 2026-06-02 | 2026-05-19 | HealthPartners Neuroscience Center Research and Innovation | Center for Drug Evaluation and Research (CDER) | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | Read the letter |
| 2026-06-02 | 2026-05-22 | Laboratorios Jaloma S.A. de C.V. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-02 | 2026-05-28 | Medline Inc | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-06-02 | 2026-05-15 | Meta Labs Pharmaceuticals, LLC | Human Foods Program | Dietary Supplement/New Drug/Misbranded | Read the letter |
| 2026-06-02 | 2026-04-15 | Stavis Seafoods, LLC | Office of Inspections and Investigations | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Read the letter |
Where this comes from
FDA publishes the warning letters it sends. Each row is one letter as the agency posted it: the company it is addressed to, the date on the letter, the date FDA posted it, the office that issued it and the agency's own subject line, with a link to the full letter. A warning letter states the agency's findings at the time it was written; it is not a final determination, and the company may have responded or since corrected the matter. Read the letter, and any response or close-out letter FDA has posted, before relying on it.
All monthsFDA device clearances
Cite this page
https://mentionfox.com/fda/warning-letters/2026-06