FDA Warning Letters, 483s and Recalls: September 2025
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Sep 30, 2025 | Allovate Therapeutics, LLC | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
| Sep 30, 2025 | Guangxi Yulin Pharmaceutical Group Co. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 26, 2025 | Technological Medical Advancements LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 25, 2025 | Creative Essences, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 25, 2025 | Naturich Cosmetique Labs | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 24, 2025 | Adja Khady Food Distribution Inc | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 24, 2025 | Las Americas Supermercado#2 Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 24, 2025 | New Life Medical Services, LLC | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
| Sep 24, 2025 | North Creek Farm | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated |
| Sep 24, 2025 | Supercan Bully Sticks LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 23, 2025 | Insung Medical Co. Ltd. | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded |
| Sep 23, 2025 | Persōn & Covey, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 22, 2025 | Kath Khemicals LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 22, 2025 | Revive Rx LLC Dba Revive Rx Pharmacy | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Sep 19, 2025 | Pamela K. Den Besten, DDS, MS | Center for Drug Evaluation and Research (CDER) | Clinical Investigator (Sponsor) |
| Sep 18, 2025 | LifeVac, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Sep 18, 2025 | Time Challenger Labs International, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Sep 17, 2025 | BRS Analytical Services, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 17, 2025 | Dixon Investments Inc. Dba ARI | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 17, 2025 | Ralph A. DeFronzo, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator/Sponsor |
| Sep 16, 2025 | Media Networks Sydney Pty. Limited | Center for Drug Evaluation and Research (CDER) | Failure to Comply with Drug Listing Requirements/Misbranded |
| Sep 16, 2025 | Stellalife, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Sep 16, 2025 | Turbare Manufacturing | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Sep 12, 2025 | Cellebration LLC | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Sep 12, 2025 | Ever Rich Foods LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 12, 2025 | Life Wholesale | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Sep 11, 2025 | Blue Forest Farms, LLC | Human Foods Program | Adulterated Human Foods/Misbranded |
| Sep 11, 2025 | Chengdu Brilliant Biopharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 11, 2025 | Columbia Cosmetics Manufacturing Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 10, 2025 | Eniva USA, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Sep 10, 2025 | Motionpharmacy.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug/Misbranded |
| Sep 9, 2025 | All American Wellness | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Amazing Meds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | ASN-LABS | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Aytu Biopharma | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | Aytu Biopharma | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | Biopreventative Company LLC Dba Biopreventative | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Bioverse, Inc. Dba Bioverse | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Body Good Studio | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Canada Med Stop | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Cosmo Medical Spa Dba Cosmo Med Spa | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | CSL Behring | Center for Biologics Evaluation and Research (CBER) | Advertising & Promotional Labeling/Drugs/Biological Products |
| Sep 9, 2025 | Dermacare LLC Dba BlueChew | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Directmeds.Com, Inc. Dba DirectMeds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | eDrugstore | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Elevate Your Wellness LLC, Dba Elevated | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Eli Lilly And Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | Eli Lilly And Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | Eli Lilly And Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | EvoLife Wellness | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Expert Aesthetics | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | FitRX, LLC Dba Zealthy | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | FWD Care, Inc. Dba FWD | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | GenLabMeds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Get.Fit.Medical, LLC Dba Get.Fit.Medical | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | GLP-1 Solution | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | HealBerry | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Healthon Inc. Dba Healthon | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Healthy Living Clinic | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Healthy Male | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Hello Cake, Inc. Dba Hello Cake | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Hims & Hers Health, Inc. Dba Hers | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Hims & Hers Health, Inc. Dba Hims | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Inspire.Clinic | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | iVisitDoc, Inc. Dba iVisitDoc | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | JulyMD | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Las Villas Health Care LLC Dba Villas Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Lean Dreams LLC Dba LeanDreams | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Lovely Meds, Inc. Dba Lovely Meds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Lumimeds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Lyfe Rx | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Mane & Steel, LLC. Dba Mane & Steel | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Master Pharmaceuticals Group | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | MedClub By Dr. Jenn | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |
| Sep 9, 2025 | Nuvo Life Health Inc. Dba Nuvo Life Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Reset IV, LLC Dba Reset IV | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Royal Philips | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Sep 9, 2025 | SemaBio | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | SimpleRx | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Slendid | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Sprout Health Partners LLC Dba Sprout Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | The HCG Institute | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | TRYM Health, Inc. Dba TRYM Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Try Nova | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Tuyo Health, Inc. Dba Tuyo Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Vitals RX | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 9, 2025 | Yangzhou Yulou Paper Products Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 9, 2025 | Ybycmeds | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Sep 8, 2025 | American Food Distributor Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Sep 8, 2025 | PureRawz | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Sep 5, 2025 | Compass Group USA | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Sep 5, 2025 | Ogle Cattle Company, Inc. | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Sep 4, 2025 | NuVida Medical LLC | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Sep 4, 2025 | Shirish M. Gadgeel, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Sep 4, 2025 | Somerset Therapeutics Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 3, 2025 | Avertix Medical, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 3, 2025 | Gracie's Kitchens, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Sep 30, 2025 | Ocho Rios Atlanta Inc. | Food/Cosmetics | United States |
| Sep 29, 2025 | Baxter Healthcare Corporation | Drugs | United States |
| Sep 29, 2025 | Lexia LLC | Drugs | United States |
| Sep 29, 2025 | Raw Bistro, Inc. | Veterinary | United States |
| Sep 26, 2025 | Abryl Laboratories Private Limited | Drugs | India |
| Sep 26, 2025 | JW Nutritional LLC | Drugs | United States |
| Sep 26, 2025 | Simtra Deutschland GmbH | Drugs | Germany |
| Sep 26, 2025 | Synlait Milk Limited | Food/Cosmetics | New Zealand |
| Sep 26, 2025 | Wa Heng Dou-Fu And Soy Sauce Corporation | Food/Cosmetics | United States |
| Sep 25, 2025 | BNC Distribution, Inc. | Tobacco | United States |
| Sep 25, 2025 | Integrity United Inc | Devices | United States |
| Sep 25, 2025 | Texas Central Distribution LLC | Tobacco | United States |
| Sep 24, 2025 | NuPack Inc | Food/Cosmetics | United States |
| Sep 23, 2025 | Christopher Dale Butler | Food/Cosmetics | United States |
| Sep 23, 2025 | JMT INTER LLC | Food/Cosmetics | United States |
| Sep 22, 2025 | Orthorebirth Co Ltd | Devices | Japan |
| Sep 19, 2025 | Daane Labs | Drugs | United States |
| Sep 19, 2025 | Diversified Ag Nutrition | Veterinary | United States |
| Sep 19, 2025 | Inventaa Chemicals Private Limited | Drugs | India |
| Sep 19, 2025 | ProRx LLC | Drugs | United States |
| Sep 19, 2025 | Thompson Farm Supply Of Baxley, LLC | Veterinary | United States |
| Sep 18, 2025 | Dezhou Lingcheng Taoyuan Food Co., Ltd. | Food/Cosmetics | China |
| Sep 18, 2025 | Immacule Lifesciences Private Limited | Veterinary | India |
| Sep 17, 2025 | Akralos Animal Nutrition LLC (DBA Hubbard Feeds) | Veterinary | United States |
| Sep 17, 2025 | A TO Z DISTRIBUTOR INC | Food/Cosmetics | United States |
| Sep 17, 2025 | Carolina Bakery Inc | Food/Cosmetics | United States |
| Sep 17, 2025 | Division Of Nuclear Medicine PET Radiopharmaceutical Production Program | Drugs | United States |
| Sep 17, 2025 | Ocean Group, Inc. | Food/Cosmetics | United States |
| Sep 16, 2025 | Fareva Amboise | Drugs | France |
| Sep 16, 2025 | Intas Pharmaceuticals Ltd. | Drugs | India |
| Sep 16, 2025 | Microbiological Testing & Consulting, LLC | Drugs | United States |
| Sep 12, 2025 | Best Buy Bones Inc. | Veterinary | United States |
| Sep 12, 2025 | BioLyte Laboratories, LLC | Drugs | United States |
| Sep 12, 2025 | Black Sheep Egg Company, LLC | Food/Cosmetics | United States |
| Sep 12, 2025 | Flowchem Pharma Private Limited | Drugs | India |
| Sep 12, 2025 | Higley Industries, Inc. | Drugs | United States |
| Sep 12, 2025 | Specialty Formulations & Manufacturing, LLC | Drugs | United States |
| Sep 10, 2025 | Diamond S Dairy | Veterinary | United States |
| Sep 9, 2025 | V & L Produce, Inc. | Food/Cosmetics | United States |
| Sep 8, 2025 | Juicer Connections, Inc. | Food/Cosmetics | United States |
| Sep 8, 2025 | Las Americas Supermercado#2 Inc. | Food/Cosmetics | United States |
| Sep 5, 2025 | Aurobindo Pharma Limited | Drugs | India |
| Sep 5, 2025 | Central Admixture Pharmacy Services, Inc. | Drugs | United States |
| Sep 5, 2025 | Central Admixture Pharmacy Services, Inc. | Drugs | United States |
| Sep 5, 2025 | Galloway Lodge Ltd | Food/Cosmetics | United Kingdom |
| Sep 5, 2025 | Keter Canada, Inc. | Devices | Canada |
| Sep 4, 2025 | Barohup Inc. | Food/Cosmetics | United States |
| Sep 4, 2025 | TOMBAK LLC | Tobacco | United States |
| Sep 3, 2025 | East Bay Wholesales Corporation | Food/Cosmetics | United States |
| Sep 3, 2025 | L'Esturgeonniere | Food/Cosmetics | France |
| Sep 3, 2025 | Oak K.K., Corporation | Food/Cosmetics | Japan |
| Sep 3, 2025 | VEOS USA, Inc. | Veterinary | United States |
| Sep 1, 2025 | KOKUYO CO.,LTD. | Food/Cosmetics | Japan |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Develop FSVP | 34 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 33 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 25 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 24 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 24 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 22 |
| 21 CFR 117.35(c) | Pest control | 22 |
| 21 CFR 211.192 | Written record of investigation incomplete | 22 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 17 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 17 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Sep 30, 2025 | B BRAUN MEDICAL INC | Devices | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. |
| Sep 30, 2025 | IMPRIS Imaging Inc | Devices | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating… |
| Sep 30, 2025 | IMPRIS Imaging Inc | Devices | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating… |
| Sep 30, 2025 | IMPRIS Imaging Inc | Devices | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating… |
| Sep 30, 2025 | IMPRIS Imaging Inc | Devices | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating… |
| Sep 29, 2025 | EGGS UNLIMITED LLC | Food | Firm received, repackaged eggs that are potentially contamination with Salmonella. |
| Sep 29, 2025 | Eli's Cheesecake Company | Food | undeclared pecan |
| Sep 29, 2025 | New Age International, Inc. | Food | Product may be contaminated with Listeria monocytogenes. |
| Sep 27, 2025 | Vicky IT Inc. | Food | Fish is un-eviscerated (may be contaminated with Clostridia botulinum), is contaminated with mold, and contains filth (insect larvae) |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled Penne pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled Penne pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled Penne pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Albertsons Companies LLC | Food | Listeria monocytogenes. Albertson's store-made deli items contain a recalled bowtie pasta ingredient which was recalled due to Listeria… |
| Sep 26, 2025 | Integra LifeSciences Corp. (NeuroSciences) | Devices | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators… |
| Sep 26, 2025 | Integra LifeSciences Corp. (NeuroSciences) | Devices | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators… |
| Sep 26, 2025 | Reser's Fine Foods, Inc. | Food | Salad Kits are recalled due to potential contamination with Listeria monocytogenes. |
| Sep 26, 2025 | Reser's Fine Foods, Inc. | Food | Salad Kits are recalled due to potential contamination with Listeria monocytogenes. |
| Sep 26, 2025 | Reser's Fine Foods, Inc. | Food | Salad Kits are recalled due to potential contamination with Listeria monocytogenes. |
| Sep 26, 2025 | The Kroger Co | Food | Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes |
| Sep 26, 2025 | The Kroger Co | Food | Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | Wegmans Food Markets, Inc. | Food | Contains undeclared pecans |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 26, 2025 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Potential Listeria monocytogenes contamination. |
| Sep 25, 2025 | BALT USA, LLC | Devices | Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 25, 2025 | Nate's Fine Foods, LLC | Food | Potential contamination with Listeria monocytogenes. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 19, 2025 | Black Sheep Egg Company, LLC | Food | Potential Salmonella contamination. |
| Sep 18, 2025 | Cook Medical Incorporated | Devices | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing… |
| Sep 18, 2025 | Garden Fresh Foods, Inc. | Food | Possible positive Listeria monocytogenes. Firm tested one lot of sliced green onions in-house and found Listeria monocytogenes. |
| Sep 18, 2025 | Western United Fish Company Inc | Food | Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result… |
| Sep 17, 2025 | D & M Smoked Fish, Inc. | Food | Contaminated with Listeria monocytogenes |
| Sep 17, 2025 | D & M Smoked Fish, Inc. | Food | Contaminated with Listeria monocytogenes |
| Sep 17, 2025 | Percussionaire Corporation | Devices | IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal… |
| Sep 16, 2025 | Abiomed, Inc. | Devices | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. |
| Sep 16, 2025 | IntegraDose Compounding Services LLC | Drugs | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. |
| Sep 11, 2025 | CareFusion 303, Inc. | Devices | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and… |
| Sep 11, 2025 | Harris Teeter | Food | Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement… |
| Sep 11, 2025 | Harris Teeter | Food | Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 11, 2025 | Olympus Corporation Of The Americas | Devices | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser… |
| Sep 10, 2025 | Abbott | Devices | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| Sep 10, 2025 | Abbott | Devices | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| Sep 10, 2025 | Abbott | Devices | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
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