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FDA warning letters

The warning letters FDA posted in the last 12 months: the company, the issuing office and the agency's own subject line, each linked to the letter.

FDA posted 657 warning letters in the last 12 months. The newest 60 are below; open a month for every letter posted in it. Each row gives the agency's own subject line and links to the letter.

By month

October 2026 (35) September 2026 (54) August 2026 (24) July 2026 (52) June 2026 (87) May 2026 (65) April 2026 (45) March 2026 (73) February 2026 (37) January 2026 (25) December 2025 (72) November 2025 (66) October 2025 (22)

Latest letters

PostedLetter dateCompanyIssuing officeSubject (FDA's words)Letter
2026-10-132026-09-22Datil Fresh Produce LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-10-132026-08-13Distribuidora Jazmin LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-10-132026-09-29Dreyer’s Grand Ice Cream, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-10-132026-10-06Eurofins SF Analytical Laboratories, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-10-132026-10-02Hanlim Pharm Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-10-132026-09-23Jiangmen Shuizirun Sanitary Articles Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-10-132026-10-02John & Nicole Santos DairyCenter for Veterinary MedicineNew Animal Drug/AdulteratedRead the letter
2026-10-132026-08-05Lewis Sausage Company Inc.Center for Veterinary MedicineCGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-10-132026-10-06Lovelace Biomedical Research InstituteCenter for Drug Evaluation and Research (CDER)Good Laboratory Practice (GLP) for Nonclinical Laboratory StudiesRead the letter
2026-10-132026-09-09Moda Food LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-10-132026-09-11Ocean Pride Seafood, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-10-132026-10-02originalc.co.ukCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-10-132026-09-11RDM Express Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-10-132026-07-22Ruukoo International Food Market Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-10-132026-09-14SCA Pharmaceuticals, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-10-132026-10-05Silgan Dispensing SystemsCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugRead the letter
2026-10-062026-10-01Aidance Scientific, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-10-01Amazon.com, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-10-01Bioactive Services USA, LLC / Herstat Inc.Center for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-09-24Cheap Medicine Shop/www.cheapmedicineshop.comCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded (Internet Pharmacy)Read the letter
2026-10-062026-10-01DesBio/Deseret Biologicals, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-09-01O.N. Diagnostics, LLCCenter for Devices and Radiological HealthMedical Device Reporting/MisbrandedRead the letter
2026-10-062026-10-01Graceful Touch, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-08-17Importaciones La Bufa LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-10-062026-09-23Online Generic Medicine/www.onlinegenericmedicine.comCenter for Drug Evaluation and Research (CDER)Unapproved New Drug/Misbranded (Internet Pharmacy)Read the letter
2026-10-062026-10-01OrganiCare, LLC / OrganiCare Nature’s Science, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-08-07Pine Pharmaceuticals, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug ProductsRead the letter
2026-10-062026-10-01The Platinum Healthcare LLCCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-10-01RoyceDerm LLCCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-09-01Star Ocean Wholesale Foods, Inc.Office of Inspections and InvestigationsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-10-062026-09-02TCI Co., Ltd BioCosme PABP BRANCHCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-10-062026-10-01TerramedCenter for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-10-062026-08-28Tipical Latin Food, Corp. DBA La PraderaHuman Foods ProgramCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary ConditionsRead the letter
2026-10-062026-09-22Unilam Co., LTDCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-10-062026-10-01Walmart, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New DrugsRead the letter
2026-09-292026-08-04American Pharma Mfg. Inc.Human Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedRead the letter
2026-09-292026-08-27Andrighetto Produce Inc dba Shasta Produce IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-292026-09-21Babikian Healthcare Products CJSCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-292026-09-17Bentley Laboratories LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedRead the letter
2026-09-292026-08-13Bo Wah Enterprises IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-292026-09-14CelmadeCenter for Drug Evaluation and Research (CDER)Review of Website/Unapproved New Drug/MisbrandedRead the letter
2026-09-292026-09-18Curia New York, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-09-292026-07-20Fil-Bay Import, Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-292026-09-22Fresenius Kabi USA LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-292026-07-02Good Stuff CacaoHuman Foods ProgramNew Drug/MisbrandedRead the letter
2026-09-292025-11-06Kellin Chemicals Co., Ltd. - ZhangjiagangCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-09-292026-03-06Middlefield Original Cheese CooperativeHuman Foods ProgramCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary ConditionsRead the letter
2026-09-292026-09-23Neogen CorporationCenter for Veterinary MedicineCGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-09-292026-09-23Sciarra Aeromed, Inc.Center for Veterinary MedicineCGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedRead the letter
2026-09-292026-09-25sfshoply.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedRead the letter
2026-09-292026-08-20South Asian Food Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-09-292026-08-04Stokes Healthcare Inc. dba Epicur PharmaCenter for Veterinary MedicineAnimal Drugs/AdulteratedRead the letter
2026-09-292026-02-02Stream2Sea, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-292026-02-09VeganicSKN LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-292026-04-20Wellmill, LLC dba Vitamix LaboratoriesHuman Foods ProgramJuice HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsRead the letter
2026-09-292026-07-24Wilson LivestockCenter for Veterinary MedicineNew Animal Drug/AdulteratedRead the letter
2026-09-222026-04-10Accra SupermarketOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-08-25Advance-Esthetic LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceRead the letter
2026-09-222026-08-18Binh Minh TofuHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedRead the letter
2026-09-222026-08-24BioDrive, Inc.Human Foods ProgramDietary Supplement/AdulteratedRead 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
Last updated 2026-10-18
FDA warning letters: 657 letters posted in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters