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FDA warning letters, June 2026

Every warning letter FDA posted in June 2026: the company, the issuing office and the agency's own subject line, each linked to the letter.

Letters87
Issuing offices6

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.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2026-06-302026-05-203B Medical, Inc. dba Reach Health, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-06-302026-06-04AseptiKits, LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceRead the letter
2026-06-302026-05-20BMC Medical Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/PMA/Adulterated/MisbrandedRead the letter
2026-06-302026-06-25Excelvision - FarevaCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-302026-05-12Flax & More CorporationHuman Foods ProgramCGMP/Dietary Supplement/AdulteratedRead the letter
2026-06-302026-06-22Genzyme Ireland LimitedCenter for Biologics Evaluation and Research (CBER)CGMP/Deviations/Biologics License Application (BLA)Read the letter
2026-06-302026-05-20Golden Dakota Farms LLCCenter for Veterinary MedicineNew Animal Drug/AdulteratedRead the letter
2026-06-302026-06-15Life & Food Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-302026-06-24Wizcure Pharmaa Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-302026-06-15Yangzhou Hongshengding Chemical Co., Ltd.Center for Drug Evaluation and Research (CDER)Refusal to Provide Access to and Copying of RecordsRead the letter
2026-06-232026-06-17Amazon.com, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-04-23Global Imports OriginsOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-232026-04-17Great Enterprise - Group - Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-232026-06-17Great India Overseas Pvt. Ltd. dba SilkruteCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-06-232026-06-17Hadassah Healing Oils LtdCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-06-232026-06-17Herbal Dermals LLC FZ dba GotucreamCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-15Huons Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-232026-06-05Imu-Tek Animal Health, IncorporatedHuman Foods ProgramDietary Supplement/New Drug/MisbrandedRead the letter
2026-06-232026-06-17Indiangoods.shopCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-17JJLBROCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-05-28Jubilant HollisterStier General PartnershipCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-232026-06-17Leading Edge Health Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-17MantroForceCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-05-26Pamex Foods IncorporatedOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-232026-06-17Telos Trading Limited dba AlwinshopCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-17Texinkart Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-08Vivot LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-232026-06-17Wholesale PeptideCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-232026-06-17Wild Arabic HerbsCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-06-162026-06-08Altru Telehealth, LLC dba Altru TelehealthCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Amie Health, Inc. dba AmieCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Clover Meds LLC dba Clover MedsCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08D&H Medical ServicesCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Eden Health International Inc. dba EdenCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Ezra Holdco LLC dba EzraCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08FITISHCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08FitRX, LLC dba AM RXCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Glow Medispa, LLC dba Mint MedCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08HydraMed IV LLC dba HydraMedCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-03InvaDerm, Inc.Center for Drug Evaluation and Research (CDER)Electronic Drug Registration and Listing System (eDRLS)/ViolationsRead the letter
2026-06-162026-06-08Joi and Blokes dba Joi + BlokesCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-02M G R Produce LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-162026-06-08Maximus Health, Inc. dba MaximusCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Medica Weight LossCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Momentum Health 360 dba Momentum HealthCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08NativeMed LLC dba NativeMedCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Nexlife Inc. dba NexlifeCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Nexus Health Solutions LLC dba Harper MedsCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Nova Vascular LLC dba NOVARXCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08OrderlyMeds LLC dba OrderlyMedsCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-05-27Pharmathen International S.A.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-06-162026-06-08Public Health Solution LLC dba DrMedHealthCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Ready MedCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Roen Health, Inc. dba RoenRxCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-05Sante Manufacturing Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-162026-06-02SL Follen CompanyOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-162026-06-08Thrivelab Co. dba ThrivelabCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08Trinity HealthCare Supply, LLC dba altRxCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08VivioMD Group LLC dba VivioMDCenter for Drug Evaluation and Research (CDER)False & Misleading Claims/Misbranded (Telehealth)Read the letter
2026-06-162026-06-08YS Group Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-162026-04-30ZOLL Medical CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-06-152026-06-15Happiest Baby, Inc.Center for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceRead the letter
2026-06-092026-06-02Asanuma Corporation - Sagamihara FactoryCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-05-14Bharat Overseas Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-092026-06-02Erkul Kozmetik Sanayi ve Ticaret A.S.Center for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-05-12Fagron BVCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug ProductsRead the letter
2026-06-092026-06-02Gopaldas Visram & Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-06-03Hubei Gedian Humanwell Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-06-092026-05-28Jose M. Carpio, M.D.Center for Drug Evaluation and Research (CDER)Clinical InvestigatorRead the letter
2026-06-092026-06-02Laboratorios Dr. Collado S.A.Center for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-05-29Macau-Union Pharmaceutical LimitedCenter for Drug Evaluation and Research (CDER)Nonprescription/OTCRead the letter
2026-06-092026-06-02PLZ CorpCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-06-02Revlon Group Holdings, LLCCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-06-02Shantou Qiwei Industry Co., LTDCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-06-02Umendra Life Sciences Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-092026-06-02Zydus Lifesciences LimitedCenter for Drug Evaluation and Research (CDER)Request for Records/CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-022026-05-22Aeroflex Industria de Aerosol Ltda.Center for Drug Evaluation and Research (CDER)Refusal to Provide Access to and Copying of RecordsRead the letter
2026-06-022026-05-20Aversa's Italian BakeryHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedRead the letter
2026-06-022026-05-26Blue Horizon International, LLCCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Unlicensed Biological Product ViolationsRead the letter
2026-06-022026-04-22Boba Factory IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-06-022026-05-15City Market, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-06-022026-05-12Dough-To-Go, Inc.Human Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedRead the letter
2026-06-022026-05-19HealthPartners Neuroscience Center Research and InnovationCenter for Drug Evaluation and Research (CDER)Good Laboratory Practice (GLP) for Nonclinical Laboratory StudiesRead the letter
2026-06-022026-05-22Laboratorios Jaloma S.A. de C.V.Center for Drug Evaluation and Research (CDER)CGMP/OTC/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-022026-05-28Medline IncCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-06-022026-05-15Meta Labs Pharmaceuticals, LLCHuman Foods ProgramDietary Supplement/New Drug/MisbrandedRead the letter
2026-06-022026-04-15Stavis Seafoods, LLCOffice of Inspections and InvestigationsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead 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.

Cite this page

Permanent URL: https://mentionfox.com/fda/warning-letters/2026-06
Last updated 2026-10-18
FDA warning letters posted in June 2026: 87 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-06