# FDA warning letters issued in 2025: 737

Updated December 30, 2025.

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)).

## 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. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-warning-letters/year/2025

SpecStream is the live web data engine for teams and agents. It reads FDA's warning letters table each morning, and this page is that reading. Ask for the offices, subjects or companies you follow and each new letter arrives in your sheet, CRM, Slack or agent as FDA posts it.

- 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.

| Issued | Company | Issuing office | Subject | Posted | Source |
| --- | --- | --- | --- | --- | --- |
| December 30, 2025 | R.R. Importaciones Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | March 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rr-importaciones-inc-719593-12302025) |
| December 30, 2025 | snuzyn.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | January 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snuzyncom-721342-12302025) |
| December 30, 2025 | bongsociety.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | January 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bongsocietycom-721343-12302025) |
| December 30, 2025 | Absolutely Natural | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | January 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/absolutely-natural-715690-12302025) |
| December 23, 2025 | LXR Biotech, LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lxr-biotech-llc-714568-12232025) |
| December 23, 2025 | Chemspec Chemicals Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chemspec-chemicals-private-limited-718403-12232025) |
| December 23, 2025 | Tower Laboratories Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | January 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tower-laboratories-ltd-717456-12232025) |
| December 22, 2025 | Meridian Bioscience, Inc | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-bioscience-inc-720826-12222025) |
| December 22, 2025 | Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purushothaman-damodara-kumaran-md-senthil-specialty-hospital-721325-12222025) |
| December 19, 2025 | Exactech, Inc. dba Advita Ortho | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exactech-inc-dba-advita-ortho-720250-12192025) |
| December 19, 2025 | LiquidCapsule Manufacturing, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | January 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/liquidcapsule-manufacturing-llc-717069-12192025) |
| December 19, 2025 | Unipack LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unipack-llc-716621-12192025) |
| December 19, 2025 | Agebox Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025) |
| December 18, 2025 | RSV Pita, Inc. DBA Pita Pan Bakery | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rsv-pita-inc-dba-pita-pan-bakery-719561-12182025) |
| December 18, 2025 | Private Label Skin Care, Inc. | Center for Drug Evaluation and Research | CGMP/OTC/Adulterated/Misbranded | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/private-label-skin-care-inc-715880-12182025) |
| December 17, 2025 | MAST Biosurgery USA, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mast-biosurgery-usa-inc-720661-12172025) |
| December 16, 2025 | Guangdong Renhe Guozhuang Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-renhe-guozhuang-biotechnology-co-ltd-719045-12162025) |
| December 16, 2025 | TOMSCOUT | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tomscout-720850-12162025) |
| December 16, 2025 | TomboyX, PBC | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tomboyx-pbc-720849-12162025) |
| December 16, 2025 | For Them, Inc. | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/them-inc-720839-12162025) |
| December 16, 2025 | TG Supply LLC d/b/a TransGuy Supply | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tg-supply-llc-dba-transguy-supply-720846-12162025) |
| December 16, 2025 | ShapeShifter Apparel, LLC | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shapeshifter-apparel-llc-720845-12162025) |
| December 16, 2025 | Philadelphia 7, Inc d/b/a Passional Boutique | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/philadelphia-7-inc-dba-passional-boutique-720843-12162025) |
| December 16, 2025 | Marli Washington Design, LLC | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/marli-washington-design-llc-720840-12162025) |
| December 16, 2025 | GenderBender LLC | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genderbender-llc-720842-12162025) |
| December 16, 2025 | Flux Lab Pte. Ltd. d/b/a The Fluxion | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flux-lab-pte-ltd-dba-fluxion-720847-12162025) |
| December 16, 2025 | FLAVNT Streetwear, LLC | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flavnt-streetwear-llc-720838-12162025) |
| December 16, 2025 | Early to Bed, Inc. | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/early-bed-inc-720822-12162025) |
| December 16, 2025 | Trans-Missie B.V. | Center for Devices and Radiological Health | Failure to Register and List/Misbranded | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trans-missie-bv-720852-12162025) |
| December 15, 2025 | Integrity Partners Group | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | January 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/integrity-partners-group-716953-12152025) |
| December 12, 2025 | MedisourceRx | Center for Drug Evaluation and Research | Compounding Pharmacy/Adulterated Drug Products | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medisourcerx-717970-12122025) |
| December 12, 2025 | TITAN SARMS LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025) |
| December 12, 2025 | Prime Sports Nutrition | Center for Drug Evaluation and Research | Unapproved New Drugs | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025) |
| December 12, 2025 | Pinnacle Professional Research dba Pinnacle Peptides | Center for Drug Evaluation and Research | Unapproved New Drugs | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025) |
| December 12, 2025 | Maria A. Carballosa, M.D. | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maria-carballosa-md-720805-12122025) |
| December 12, 2025 | Dynamic Health Group dba SARMS AMERICA | Center for Drug Evaluation and Research | Unapproved New Drugs | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-health-group-dba-sarms-america-719257-12122025) |
| December 12, 2025 | Atomix LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025) |
| December 12, 2025 | Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025) |
| December 12, 2025 | Walmart, Inc. | Human Foods Program | Infant Botulism Outbreak | December 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-720400-12122025) |
| December 12, 2025 | Target Corporation | Human Foods Program | Infant Botulism Outbreak | December 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/target-corporation-720399-12122025) |
| December 12, 2025 | The Kroger Company | Human Foods Program | Infant Botulism Outbreak | December 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kroger-company-720464-12122025) |
| December 12, 2025 | The Albertsons Companies Incorporated | Human Foods Program | Infant Botulism Outbreak | December 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/albertsons-companies-incorporated-720465-12122025) |
| December 11, 2025 | BNC Distribution Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bnc-distribution-inc-719765-12112025) |
| December 11, 2025 | Palamur Biosciences Private Limited | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/palamur-biosciences-private-limited-708579-12112025) |
| December 11, 2025 | Devalingam Mahalingam, M.D., Ph.D. | Center for Drug Evaluation and Research | Clinical Investigator | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/devalingam-mahalingam-md-phd-721145-12112025) |
| December 11, 2025 | Upper Limits | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/upper-limits-719675-12112025) |
| December 10, 2025 | Maui Seafood LLC | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maui-seafood-llc-715844-12102025) |
| December 10, 2025 | Medinatura New Mexico, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medinatura-new-mexico-inc-716025-12102025) |
| December 9, 2025 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asp-global-llc-dba-anatomy-supply-partners-llc-718444-12092025) |
| December 9, 2025 | SV Labs Corporation | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sv-labs-corporation-716503-12092025) |
| December 9, 2025 | Sklar Personal Care Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sklar-personal-care-inc-716656-12092025) |
| December 8, 2025 | Darmerica, LLC | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025) |
| December 5, 2025 | relevantvapes.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/relevantvapescom-720466-12052025) |
| December 5, 2025 | giantvapes.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/giantvapescom-720366-12052025) |
| December 4, 2025 | King Farm | Center for Veterinary Medicine | CGMP/Animal Food/Adulterated | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/king-farm-713276-12042025) |
| December 4, 2025 | 3D Imaging Drug Design and Development LLC | Center for Drug Evaluation and Research | CGMP/Positron Emission Tomography (PET) Drugs/Adulterated | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/3d-imaging-drug-design-and-development-llc-716213-12042025) |
| December 4, 2025 | KMT Distribution LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kmt-distribution-llc-719954-12042025) |
| December 4, 2025 | The Vape Shop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 4, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vape-shop-719435-12042025) |
| December 3, 2025 | Microvascular Tissue, Inc. | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/microvascular-tissue-inc-710860-12032025) |
| December 3, 2025 | Green Valley Fertility Partners | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-valley-fertility-partners-720249-12032025) |
| December 1, 2025 | Apothecary Pharma, LLC | Center for Drug Evaluation and Research | Compounding Pharmacy/Adulterated Drug Products | March 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025) |
| December 1, 2025 | Seaway Pharma Inc. | Office of Manufacturing Quality | CGMP/Finished Pharmaceuticals/Adulterated | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seaway-pharma-inc-717355-12012025) |
| December 1, 2025 | Celularity, Inc | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celularity-inc-681480-12012025) |
| December 1, 2025 | BioXtek LLC | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bioxtek-llc-715478-12012025) |
| November 28, 2025 | Yuyao City Boss Vegetable Factory Co. Ltd. | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated | March 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yuyao-city-boss-vegetable-factory-co-ltd-717174-11282025) |
| November 28, 2025 | John Yoder Farm | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated | March 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/john-yoder-farm-716077-11282025) |
| November 28, 2025 | The Father's Table, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | March 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fathers-table-llc-706334-11282025) |
| November 28, 2025 | Harbor Marine Product Inc. | Office of Compliance and Enforcement | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbor-marine-product-inc-710589-11282025) |
| November 28, 2025 | Delucas Bakery Corp | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | December 2, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/delucas-bakery-corp-710348-11282025) |
| November 26, 2025 | virginiavapes.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/virginiavapescom-720134-11262025) |
| November 26, 2025 | elfbarvapesusa.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/elfbarvapesusacom-720115-11262025) |
| November 25, 2025 | Asli Foods, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asli-foods-inc-719578-11252025) |
| November 25, 2025 | Lux Therapeutics LLC dba Ponya Therapeutics LLC | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lux-therapeutics-llc-dba-ponya-therapeutics-llc-720001-11252025) |
| November 24, 2025 | CDL Services, Inc. DBA Technichem | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdl-services-inc-dba-technichem-713877-11242025) |
| November 24, 2025 | Texas Central Distribution LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/texas-central-distribution-llc-719734-11242025) |
| November 20, 2025 | Aaa International Seafood Corp. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | May 5, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aaa-international-seafood-corp-718535-11202025) |
| November 20, 2025 | smokespotvape.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smokespotvapecom-719890-11202025) |
| November 20, 2025 | Catalent Indiana, LLC | Office of Manufacturing Quality | CGMP/Finished Pharmaceuticals/Adulterated | December 11, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/catalent-indiana-llc-718189-11202025) |
| November 20, 2025 | Wisemen Wholesale, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wisemen-wholesale-inc-719714-11202025) |
| November 17, 2025 | Bedner Growers, Inc. | Human Foods Program | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bedner-growers-inc-706726-11172025) |
| November 17, 2025 | VarunKart Group LLC dba Organic Wellnesses | Center for Drug Evaluation and Research | Unapproved New Drugs | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/varunkart-group-llc-dba-organic-wellnesses-716154-11172025) |
| November 17, 2025 | Swift Digital Group LLC dba Swadesii | Center for Drug Evaluation and Research | Unapproved New Drugs | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swift-digital-group-llc-dba-swadesii-716644-11172025) |
| November 17, 2025 | Mahita LLC dba PushMyCart | Center for Drug Evaluation and Research | Unapproved New Drugs | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mahita-llc-dba-pushmycart-716286-11172025) |
| November 17, 2025 | Handelnine Global, LLC dba Navafresh | Center for Drug Evaluation and Research | Unapproved New Drugs/Adulterated/Misbranded | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/handelnine-global-llc-dba-navafresh-716013-11172025) |
| November 17, 2025 | Distacart Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/distacart-inc-716212-11172025) |
| November 14, 2025 | earthsbountyjuice.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/earthsbountyjuicecom-719635-11142025) |
| November 14, 2025 | lowkeydis.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lowkeydiscom-719647-11142025) |
| November 13, 2025 | Pan-African Food Distributors Inc./East Africa Boutique LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pan-african-food-distributors-inceast-africa-boutique-llc-717171-11132025) |
| November 13, 2025 | Longford Water Company LLC | Office of Compliance and Enforcement | Processing & Bottling of Bottled Drinking Water Regulations/Adulterated | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/longford-water-company-llc-708114-11132025) |
| November 13, 2025 | Connor Provisions, Inc., d/b/a Basic Liquid | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/connor-provisions-inc-dba-basic-liquid-719562-11132025) |
| November 13, 2025 | Shoplet | Center for Drug Evaluation and Research | Nonprescription/OTC | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoplet-717846-11132025) |
| November 13, 2025 | Seema International | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seema-international-716072-11132025) |
| November 13, 2025 | Save Rite Medical | Center for Drug Evaluation and Research | Nonprescription/OTC | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/save-rite-medical-717838-11132025) |
| November 13, 2025 | Medical Mega | Center for Drug Evaluation and Research | Nonprescription/OTC | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-mega-717840-11132025) |
| November 13, 2025 | Cdymax India Pharma Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdymax-india-pharma-private-limited-715022-11132025) |
| November 13, 2025 | 123Herbals | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/123herbals-719198-11132025) |
| November 13, 2025 | You Suck Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | November 17, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/you-suck-vapes-716275-11132025) |
| November 12, 2025 | Physitemp Instruments, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 31, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/physitemp-instruments-llc-717394-11122025) |
| November 12, 2025 | DeVere Manufacturing Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/devere-manufacturing-inc-715846-11122025) |
| November 12, 2025 | Rhyz Analytical Labs | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | December 2, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhyz-analytical-labs-715298-11122025) |

## By subject group

| Subject group | Letters | Latest |
| --- | --- | --- |
| [Tobacco products](https://specstream.ai/data/fda-warning-letters/subject/tobacco) | 232 | December 30, 2025 |
| [Unapproved drugs, marketing and online sales](https://specstream.ai/data/fda-warning-letters/subject/drug-marketing-and-online-sales) | 200 | December 19, 2025 |
| [Drug manufacturing (CGMP)](https://specstream.ai/data/fda-warning-letters/subject/drug-manufacturing) | 110 | December 30, 2025 |
| [Food safety](https://specstream.ai/data/fda-warning-letters/subject/food-safety) | 71 | December 30, 2025 |
| [Medical devices](https://specstream.ai/data/fda-warning-letters/subject/medical-devices) | 47 | December 22, 2025 |
| [Clinical research and labs](https://specstream.ai/data/fda-warning-letters/subject/clinical-research) | 18 | December 22, 2025 |
| [Biologics, cells and tissue](https://specstream.ai/data/fda-warning-letters/subject/biologics-and-tissue) | 17 | December 3, 2025 |
| [Drug compounding](https://specstream.ai/data/fda-warning-letters/subject/compounding) | 14 | December 12, 2025 |
| [Dietary supplements](https://specstream.ai/data/fda-warning-letters/subject/dietary-supplements) | 13 | December 23, 2025 |
| [Animal drugs and feed](https://specstream.ai/data/fda-warning-letters/subject/animal-drugs-and-feed) | 12 | December 4, 2025 |
| Other subjects | 3 | November 13, 2025 |

## By issuing office

| Issuing office | Letters | Latest |
| --- | --- | --- |
| [Center for Drug Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-drug-evaluation-and-research) | 314 | December 30, 2025 |
| [Center for Tobacco Products](https://specstream.ai/data/fda-warning-letters/office/center-for-tobacco-products) | 233 | December 30, 2025 |
| [Center for Devices and Radiological Health](https://specstream.ai/data/fda-warning-letters/office/center-for-devices-and-radiological-health) | 61 | December 22, 2025 |
| [Human Foods Program](https://specstream.ai/data/fda-warning-letters/office/human-foods-program) | 54 | December 23, 2025 |
| [Center for Biologics Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-biologics-evaluation-and-research) | 17 | December 3, 2025 |
| [Center for Veterinary Medicine](https://specstream.ai/data/fda-warning-letters/office/center-for-veterinary-medicine) | 15 | December 9, 2025 |
| [Division of Northeast Imports](https://specstream.ai/data/fda-warning-letters/office/division-of-northeast-imports) | 10 | October 15, 2025 |
| [Office of Inspections and Investigations](https://specstream.ai/data/fda-warning-letters/office/office-of-inspections-and-investigations) | 8 | December 30, 2025 |
| Division of Southwest Imports | 6 | September 24, 2025 |
| Division of West Coast Imports | 4 | October 9, 2025 |
| Office of Manufacturing Quality | 3 | December 1, 2025 |
| Office of Compliance and Biologics Quality | 3 | December 1, 2025 |
| Division of Southeast Imports | 3 | October 24, 2025 |
| Office of Compliance and Enforcement | 2 | November 28, 2025 |
| The Office of Prescription Drug Promotion | 2 | May 29, 2025 |
| Office of Unapproved Drugs and Labeling Compliance | 1 | May 30, 2025 |
| ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality | 1 | January 21, 2025 |

## Where FDA publishes its warning letters

- [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/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](https://creativecommons.org/licenses/by/4.0/).