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Data / FDA warning letters / 2025

FDA warning letters issued in 2025: 737

The full list. FDA warning letters issued in 2025: 737 rows for $36.85, FDA warning letters issued November 12, 2024 to October 30, 2026.

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For agents and scripts: this list is ordered at https://specstream.ai/data/fda-warning-letters/year/2025, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated December 30, 2025. Source: FDA warning letters (U.S. Food and Drug Administration).

FDA issued 737 warning letters in 2025 from January 2, 2025 to December 30, 2025, to 707 companies; 32 have a closeout letter. The newest, issued December 30, 2025 by the Office of Inspections and Investigations, went to R.R. Importaciones Inc. (Foreign Supplier Verification Program (FSVP)).

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Letters
737
With closeout
32
Latest issued
December 30, 2025

Newest letters

The newest 100 of 737 by issue date, each linked to the letter on fda.gov.

IssuedCompanyIssuing officeSubjectPostedSource
December 30, 2025R.R. Importaciones Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)March 3, 2026fda.gov
December 30, 2025snuzyn.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedJanuary 6, 2026fda.gov
December 30, 2025bongsociety.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedJanuary 6, 2026fda.gov
December 30, 2025Absolutely NaturalCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJanuary 6, 2026fda.gov
December 23, 2025LXR Biotech, LLCHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedJanuary 13, 2026fda.gov
December 23, 2025Chemspec Chemicals Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJanuary 13, 2026fda.gov
December 23, 2025Tower Laboratories Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJanuary 6, 2026fda.gov
December 22, 2025Meridian Bioscience, IncCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 27, 2026fda.gov
December 22, 2025Purushothaman Damodara Kumaran, M.D. / Senthil Specialty HospitalCenter for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalJanuary 13, 2026fda.gov
December 19, 2025Exactech, Inc. dba Advita OrthoCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedMarch 10, 2026fda.gov
December 19, 2025LiquidCapsule Manufacturing, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJanuary 6, 2026fda.gov
December 19, 2025Unipack LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 30, 2025fda.gov
December 19, 2025Agebox Inc.Center for Drug Evaluation and ResearchUnapproved New Drug/MisbrandedDecember 30, 2025fda.gov
December 18, 2025RSV Pita, Inc. DBA Pita Pan BakeryHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedMay 5, 2026fda.gov
December 18, 2025Private Label Skin Care, Inc.Center for Drug Evaluation and ResearchCGMP/OTC/Adulterated/MisbrandedDecember 30, 2025fda.gov
December 17, 2025MAST Biosurgery USA, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 27, 2026fda.gov
December 16, 2025Guangdong Renhe Guozhuang Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 23, 2025fda.gov
December 16, 2025TOMSCOUTCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025TomboyX, PBCCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025For Them, Inc.Center for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025TG Supply LLC d/b/a TransGuy SupplyCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025ShapeShifter Apparel, LLCCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025Philadelphia 7, Inc d/b/a Passional BoutiqueCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025Marli Washington Design, LLCCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025GenderBender LLCCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025Flux Lab Pte. Ltd. d/b/a The FluxionCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025FLAVNT Streetwear, LLCCenter for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025Early to Bed, Inc.Center for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 18, 2025fda.gov
December 16, 2025Trans-Missie B.V.Center for Devices and Radiological HealthFailure to Register and List/MisbrandedDecember 16, 2025fda.gov
December 15, 2025Integrity Partners GroupCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJanuary 20, 2026fda.gov
December 12, 2025MedisourceRxCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsFebruary 24, 2026fda.gov
December 12, 2025TITAN SARMS LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsDecember 23, 2025fda.gov
December 12, 2025Prime Sports NutritionCenter for Drug Evaluation and ResearchUnapproved New DrugsDecember 23, 2025fda.gov
December 12, 2025Pinnacle Professional Research dba Pinnacle PeptidesCenter for Drug Evaluation and ResearchUnapproved New DrugsDecember 23, 2025fda.gov
December 12, 2025Maria A. Carballosa, M.D.Center for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalDecember 23, 2025fda.gov
December 12, 2025Dynamic Health Group dba SARMS AMERICACenter for Drug Evaluation and ResearchUnapproved New DrugsDecember 23, 2025fda.gov
December 12, 2025Atomix LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsDecember 23, 2025fda.gov
December 12, 2025Musclepower Enterprise Ltd. dba MONSTER KING and GE LABSCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 16, 2025fda.gov
December 12, 2025Walmart, Inc.Human Foods ProgramInfant Botulism OutbreakDecember 15, 2025fda.gov
December 12, 2025Target CorporationHuman Foods ProgramInfant Botulism OutbreakDecember 15, 2025fda.gov
December 12, 2025The Kroger CompanyHuman Foods ProgramInfant Botulism OutbreakDecember 15, 2025fda.gov
December 12, 2025The Albertsons Companies IncorporatedHuman Foods ProgramInfant Botulism OutbreakDecember 15, 2025fda.gov
December 11, 2025BNC Distribution Inc.Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedFebruary 10, 2026fda.gov
December 11, 2025Palamur Biosciences Private LimitedCenter for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesDecember 30, 2025fda.gov
December 11, 2025Devalingam Mahalingam, M.D., Ph.D.Center for Drug Evaluation and ResearchClinical InvestigatorDecember 30, 2025fda.gov
December 11, 2025Upper LimitsCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 16, 2025fda.gov
December 10, 2025Maui Seafood LLCHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsFebruary 10, 2026fda.gov
December 10, 2025Medinatura New Mexico, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 23, 2025fda.gov
December 9, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 13, 2026fda.gov
December 9, 2025SV Labs CorporationCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/AdulteratedDecember 23, 2025fda.gov
December 9, 2025Sklar Personal Care Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 16, 2025fda.gov
December 8, 2025Darmerica, LLCCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated/MisbrandedDecember 23, 2025fda.gov
December 5, 2025relevantvapes.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 16, 2025fda.gov
December 5, 2025giantvapes.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 16, 2025fda.gov
December 4, 2025King FarmCenter for Veterinary MedicineCGMP/Animal Food/AdulteratedDecember 23, 2025fda.gov
December 4, 20253D Imaging Drug Design and Development LLCCenter for Drug Evaluation and ResearchCGMP/Positron Emission Tomography (PET) Drugs/AdulteratedDecember 16, 2025fda.gov
December 4, 2025KMT Distribution LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 9, 2025fda.gov
December 4, 2025The Vape ShopCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 4, 2025fda.gov
December 3, 2025Microvascular Tissue, Inc.Center for Biologics Evaluation and ResearchCGMP/Deviations/Biologics License Application (BLA)December 16, 2025fda.gov
December 3, 2025Green Valley Fertility PartnersCenter for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)December 16, 2025fda.gov
December 1, 2025Apothecary Pharma, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 17, 2026fda.gov
December 1, 2025Seaway Pharma Inc.Office of Manufacturing QualityCGMP/Finished Pharmaceuticals/AdulteratedDecember 9, 2025fda.gov
December 1, 2025Celularity, IncOffice of Compliance and Biologics QualityUnapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)December 9, 2025fda.gov
December 1, 2025BioXtek LLCOffice of Compliance and Biologics QualityUnapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)December 9, 2025fda.gov
November 28, 2025Yuyao City Boss Vegetable Factory Co. Ltd.Human Foods ProgramAcidified Foods/Emergency Permit Control/AdulteratedMarch 3, 2026fda.gov
November 28, 2025John Yoder FarmHuman Foods ProgramPHS Act/Shell Egg Regulation/AdulteratedMarch 3, 2026fda.gov
November 28, 2025The Father's Table, LLCHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenesMarch 3, 2026fda.gov
November 28, 2025Harbor Marine Product Inc.Office of Compliance and EnforcementSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsDecember 16, 2025fda.gov
November 28, 2025Delucas Bakery CorpHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedDecember 2, 2025fda.gov
November 26, 2025virginiavapes.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 9, 2025fda.gov
November 26, 2025elfbarvapesusa.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 9, 2025fda.gov
November 25, 2025Asli Foods, IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)January 27, 2026fda.gov
November 25, 2025Lux Therapeutics LLC dba Ponya Therapeutics LLCOffice of Compliance and Biologics QualityUnapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)December 9, 2025fda.gov
November 24, 2025CDL Services, Inc. DBA TechnichemCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 9, 2025fda.gov
November 24, 2025Texas Central Distribution LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 25, 2025fda.gov
November 20, 2025Aaa International Seafood Corp.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsMay 5, 2026fda.gov
November 20, 2025smokespotvape.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 30, 2025fda.gov
November 20, 2025Catalent Indiana, LLCOffice of Manufacturing QualityCGMP/Finished Pharmaceuticals/AdulteratedDecember 11, 2025fda.gov
November 20, 2025Wisemen Wholesale, Inc.Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 25, 2025fda.gov
November 17, 2025Bedner Growers, Inc.Human Foods ProgramFood/Prepared Packed or Held Under Insanitary Conditions/AdulteratedDecember 16, 2025fda.gov
November 17, 2025VarunKart Group LLC dba Organic WellnessesCenter for Drug Evaluation and ResearchUnapproved New DrugsNovember 25, 2025fda.gov
November 17, 2025Swift Digital Group LLC dba SwadesiiCenter for Drug Evaluation and ResearchUnapproved New DrugsNovember 25, 2025fda.gov
November 17, 2025Mahita LLC dba PushMyCartCenter for Drug Evaluation and ResearchUnapproved New DrugsNovember 25, 2025fda.gov
November 17, 2025Handelnine Global, LLC dba NavafreshCenter for Drug Evaluation and ResearchUnapproved New Drugs/Adulterated/MisbrandedNovember 25, 2025fda.gov
November 17, 2025Distacart Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsNovember 25, 2025fda.gov
November 14, 2025earthsbountyjuice.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 25, 2025fda.gov
November 14, 2025lowkeydis.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 18, 2025fda.gov
November 13, 2025Pan-African Food Distributors Inc./East Africa Boutique LLCHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/MisbrandedJanuary 13, 2026fda.gov
November 13, 2025Longford Water Company LLCOffice of Compliance and EnforcementProcessing & Bottling of Bottled Drinking Water Regulations/AdulteratedDecember 16, 2025fda.gov
November 13, 2025Connor Provisions, Inc., d/b/a Basic LiquidCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 25, 2025fda.gov
November 13, 2025ShopletCenter for Drug Evaluation and ResearchNonprescription/OTCNovember 18, 2025fda.gov
November 13, 2025Seema InternationalCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNovember 18, 2025fda.gov
November 13, 2025Save Rite MedicalCenter for Drug Evaluation and ResearchNonprescription/OTCNovember 18, 2025fda.gov
November 13, 2025Medical MegaCenter for Drug Evaluation and ResearchNonprescription/OTCNovember 18, 2025fda.gov
November 13, 2025Cdymax India Pharma Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNovember 18, 2025fda.gov
November 13, 2025123HerbalsCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 18, 2025fda.gov
November 13, 2025You Suck VapesCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 17, 2025fda.gov
November 12, 2025Physitemp Instruments, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedMarch 31, 2026fda.gov
November 12, 2025DeVere Manufacturing Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 9, 2025fda.gov
November 12, 2025Rhyz Analytical LabsCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 2, 2025fda.gov

By subject group

Subject groupLettersLatest
Tobacco products232December 30, 2025
Unapproved drugs, marketing and online sales200December 19, 2025
Drug manufacturing (CGMP)110December 30, 2025
Food safety71December 30, 2025
Medical devices47December 22, 2025
Clinical research and labs18December 22, 2025
Biologics, cells and tissue17December 3, 2025
Drug compounding14December 12, 2025
Dietary supplements13December 23, 2025
Animal drugs and feed12December 4, 2025
Other subjects3November 13, 2025

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research314December 30, 2025
Center for Tobacco Products233December 30, 2025
Center for Devices and Radiological Health61December 22, 2025
Human Foods Program54December 23, 2025
Center for Biologics Evaluation and Research17December 3, 2025
Center for Veterinary Medicine15December 9, 2025
Division of Northeast Imports10October 15, 2025
Office of Inspections and Investigations8December 30, 2025
Division of Southwest Imports6September 24, 2025
Division of West Coast Imports4October 9, 2025
Office of Manufacturing Quality3December 1, 2025
Office of Compliance and Biologics Quality3December 1, 2025
Division of Southeast Imports3October 24, 2025
Office of Compliance and Enforcement2November 28, 2025
The Office of Prescription Drug Promotion2May 29, 2025
Office of Unapproved Drugs and Labeling Compliance1May 30, 2025
ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality1January 21, 2025

Where FDA publishes its warning letters

Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.