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FDA warning letters, September 2026

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

Letters54
Issuing offices8

FDA posted 54 warning letters in September 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 22; Office of Inspections and Investigations 12; Human Foods Program 8; Center for Veterinary Medicine 6; Center for Devices and Radiological Health 3; and others. Each row gives the agency's own subject line and links to the letter.

PostedLetter dateCompanyIssuing officeSubject (FDA's words)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
2026-09-222026-09-18Empower Clinic Services, LLC dba Empower PharmacyCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugRead the letter
2026-09-222026-09-08kdc/one Chatsworth, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-222026-07-15LDNN Produce Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-08-21Lion Street Medical, d/b/a Pensar Medical LLCCenter for Devices and Radiological HealthMedical Device Reporting/MisbrandedRead the letter
2026-09-222026-09-11NexCell Scientific IncCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Unlicensed Biological Product ViolationsRead the letter
2026-09-222026-07-22Ohom Padmaavathii, LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-08-05Quantum Star LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-08-21Raaw Energy LLCCenter for Veterinary MedicineAdulterated Animal Foods/MisbrandedRead the letter
2026-09-222026-06-26Shouly Import Corp.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-07-07Specialty Health Products CO, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedRead the letter
2026-09-222026-08-27Union Trade Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-222026-08-05Viva Raw LLCCenter for Veterinary MedicineAdulterated Animal Foods/MisbrandedRead the letter
2026-09-222026-06-01Yam Man Foods LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-152026-09-04Bausch & Lomb Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-152026-07-31H2 BEV, LLC and H2 RENU, INCHuman Foods ProgramAcidified Foods/Emergency Permit Control/Adulterated/MisbrandedRead the letter
2026-09-082026-09-01Happy Farm Botanicals, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-082026-08-27Stephen J. Fallon, Ph.D.Center for Biologics Evaluation and Research (CBER)Bioresearch Monitoring Program/Institutional Review Board (IRB)Read the letter
2026-09-012026-08-18B&P Mutual CorpOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-012026-08-25Fresenius Medical Care AG & Co. KGaACenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-012026-08-27Jabil Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-012026-08-04Mesquite Gourmet LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)Read the letter
2026-09-012026-08-24NuScience Peptides LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-09-012026-08-24Peak Performance PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-09-012026-08-24Peptide Partners LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-09-012026-08-18PReye, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugRead the letter
2026-09-012026-08-18Reliance Life Sciences Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/AdulteratedRead the letter
2026-09-012026-08-24Royal Peptides LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead the letter
2026-09-012026-08-18Shoolin Pharma Chem LLPCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedRead the letter
2026-09-012026-08-24TXP Innovations LLC dba Tex PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/MisbrandedRead 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/2026-09
Last updated 2026-10-18
FDA warning letters posted in September 2026: 54 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-09