FDA Warning Letters, 483s and Recalls: November 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 |
|---|---|---|---|
| Nov 28, 2025 | Harbor Marine Product Inc. | Office of Compliance and Enforcement | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Nov 28, 2025 | John Yoder Farm | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated |
| Nov 28, 2025 | The Father's Table, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Nov 28, 2025 | Yuyao City Boss Vegetable Factory Co. Ltd. | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated |
| Nov 25, 2025 | Asli Foods, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Nov 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) |
| Nov 24, 2025 | CDL Services, Inc. DBA Technichem | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 20, 2025 | Aaa International Seafood Corp. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Nov 20, 2025 | Catalent Indiana, LLC | Office of Manufacturing Quality | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 17, 2025 | Bedner Growers, Inc. | Human Foods Program | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
| Nov 17, 2025 | Distacart Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Nov 17, 2025 | Handelnine Global, LLC Dba Navafresh | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Adulterated/Misbranded |
| Nov 17, 2025 | Mahita LLC Dba PushMyCart | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Nov 17, 2025 | Swift Digital Group LLC Dba Swadesii | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Nov 17, 2025 | VarunKart Group LLC Dba Organic Wellnesses | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Nov 13, 2025 | 123Herbals | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Nov 13, 2025 | Cdymax India Pharma Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Nov 13, 2025 | Longford Water Company LLC | Office of Compliance and Enforcement | Processing & Bottling of Bottled Drinking Water Regulations/Adulterated |
| Nov 13, 2025 | Medical Mega | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC |
| Nov 13, 2025 | Pan-African Food Distributors Inc./East Africa Boutique LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Nov 13, 2025 | Save Rite Medical | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC |
| Nov 13, 2025 | Shoplet | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC |
| Nov 12, 2025 | DeVere Manufacturing Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 12, 2025 | Physitemp Instruments, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Nov 12, 2025 | Rhyz Analytical Labs | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 12, 2025 | Sinsin Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC |
| Nov 11, 2025 | Envoy Medical Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Nov 10, 2025 | Verdure Sciences, Inc. | Center for Drug Evaluation and Research (CDER) | Sponsor/Investigator |
| Nov 7, 2025 | Wells Pharma Of Houston, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Nov 6, 2025 | Kellin Chemicals Co., Ltd. - Zhangjiagang | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Nov 4, 2025 | Siddha Flower Essences, LLC., Dba Siddha Remedies | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 3, 2025 | AceCosm | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox Blitz |
| Nov 3, 2025 | Aesthetic Essentials Limited | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox Blitz |
| Nov 3, 2025 | CelestaPro | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | Cosmenic | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | COSMO KOREA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
| Nov 3, 2025 | Dermacare Dba Filler Outlet | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | Derma Solution | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
| Nov 3, 2025 | Dermax Co., Ltd | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox Blitz |
| Nov 3, 2025 | Elle Pharm | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox Blitz |
| Nov 3, 2025 | Estaderma | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | Glam Derma | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
| Nov 3, 2025 | Glowface | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
| Nov 3, 2025 | Glow Nest Beauty | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox Blitz |
| Nov 3, 2025 | Korean Aesthetic Dba Korean Fillers | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | Maypharm | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |
| Nov 3, 2025 | Meamo | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
| Nov 3, 2025 | Miers Laboratories, Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Nov 3, 2025 | MJS Medicals | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/Botox |
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 |
|---|---|---|---|
| Nov 27, 2025 | Gland Chemicals Private Limited | Drugs | India |
| Nov 24, 2025 | Mineral BioSciences, LLC. | Food/Cosmetics | United States |
| Nov 21, 2025 | B. Braun US Pharmaceutical Manufacturing, LLC | Drugs | United States |
| Nov 21, 2025 | Hunan Xiangyikang Pharmaceutical Co., Ltd. | Veterinary | China |
| Nov 21, 2025 | Huons Co., Ltd. | Drugs | Korea (the Republic of) |
| Nov 21, 2025 | Merle Norman Cosmetics, Inc. | Drugs | United States |
| Nov 21, 2025 | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | Devices | Japan |
| Nov 21, 2025 | Olympus Medical Systems Corporation | Devices | Japan |
| Nov 21, 2025 | Olympus Winter & IBE Gmbh | Devices | Germany |
| Nov 21, 2025 | Pharmathen International S.A. | Drugs | Greece |
| Nov 21, 2025 | Relax Relief Rejuvenate Trading LLC | Food/Cosmetics | United States |
| Nov 21, 2025 | Sato Pharmaceutical Co., Ltd. | Drugs | Japan |
| Nov 19, 2025 | Blephex, LLC | Devices | United States |
| Nov 19, 2025 | Vanity Vision | Food/Cosmetics | India |
| Nov 19, 2025 | Vintage Chemical, Inc. | Drugs | United States |
| Nov 18, 2025 | Chartwell Pharmaceuticals Congers, LLC | Drugs | United States |
| Nov 18, 2025 | THE HIGGINS GROUP CORP. | Veterinary | United States |
| Nov 14, 2025 | Empower Clinic Services, LLC | Drugs | United States |
| Nov 14, 2025 | EUGIA Pharma Specialities Limited | Drugs | India |
| Nov 14, 2025 | Pine Pharmaceuticals, LLC | Drugs | United States |
| Nov 14, 2025 | Shirakawa Olympus Co., Ltd. | Devices | Japan |
| Nov 14, 2025 | TIANJIN HUBAO CONDIMENTS BREWING CO.,LTD. | Food/Cosmetics | China |
| Nov 13, 2025 | IDO PHARM | Drugs | Korea (the Republic of) |
| Nov 13, 2025 | Shian Jia Meei Enterprise Co., Ltd. | Devices | Taiwan |
| Nov 12, 2025 | FORDOZ PHARMA CO. | Drugs | United States |
| Nov 12, 2025 | SHEPHERD BOY FARMS | Veterinary | United States |
| Nov 11, 2025 | Empacadora Lota Seafoods S.A. | Food/Cosmetics | Chile |
| Nov 11, 2025 | Rizhao Rongjin Aquatic Products Co., Ltd. | Food/Cosmetics | China |
| Nov 10, 2025 | ZENITH FOODS LLC | Food/Cosmetics | United States |
| Nov 7, 2025 | DANDONG SAMJIN FOOD CO.,LTD | Food/Cosmetics | China |
| Nov 7, 2025 | Harbin Jixianglong Biotech Co., Ltd. | Drugs | China |
| Nov 7, 2025 | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. | Drugs | China |
| Nov 6, 2025 | African Food On Wheels Inc. | Food/Cosmetics | United States |
| Nov 5, 2025 | Fresenius Kabi Compounding, LLC | Drugs | United States |
| Nov 5, 2025 | Intuitive Surgical, Inc. | Devices | United States |
| Nov 4, 2025 | Sichuan Cai Hua Xiang Food Co., Ltd | Food/Cosmetics | China |
| Nov 3, 2025 | Deep Foods Inc. | Food/Cosmetics | United States |
| Nov 3, 2025 | Jubilant HollisterStier General Partnership | Veterinary | Canada |
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 820.100(a) | Lack of or inadequate procedures | 24 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 21 |
| 21 CFR 211.192 | No written record of investigation | 18 |
| 21 CFR 117.35(c) | Pest control | 15 |
| 21 CFR 1.502(a) | FSVP assurances | 15 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 15 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 14 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 13 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 13 |
| 21 CFR 111.70(b) | Specifications - components | 12 |
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 |
|---|---|---|---|
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 26, 2025 | Medline Industries, LP | Devices | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical… |
| Nov 24, 2025 | Abbott Diabetes Care, Inc. | Devices | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| Nov 24, 2025 | Abbott Diabetes Care, Inc. | Devices | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| Nov 24, 2025 | Abbott Diabetes Care, Inc. | Devices | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| Nov 24, 2025 | Abbott Diabetes Care, Inc. | Devices | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| Nov 24, 2025 | Alcon Research LLC | Devices | Ophthalmic procedure packs may have incomplete seals affecting sterility. |
| Nov 24, 2025 | Draeger, Inc. | Devices | A certain component of affected devices was not delivered within specification and contained impurities. |
| Nov 24, 2025 | Draeger, Inc. | Devices | A certain component of affected devices was not delivered within specification and contained impurities. |
| Nov 22, 2025 | GBC Food Services, LLC | Food | Potential presence of Listeria monocytogenes. |
| Nov 22, 2025 | GBC Food Services, LLC | Food | Potential presence of Listeria monocytogenes. |
| Nov 22, 2025 | Wegmans Food Markets, Inc. | Food | Product may be contaminated with Listeria monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Ambriola Co., Inc., The | Food | Product tested positive for Listeria Monocytogenes. |
| Nov 21, 2025 | Lotus Mom Corporation Dba Indian Kitchen Mart | Food | Potential contamination with leachable lead. |
| Nov 21, 2025 | Silvestri Sweets Inc Dba Carousel Candies | Food | Undeclared wheat |
| Nov 21, 2025 | Silvestri Sweets Inc Dba Carousel Candies | Food | Undeclared pecan |
| Nov 21, 2025 | The Whole Herb Company, Inc. | Food | Potential contamination with Salmonella. |
| Nov 20, 2025 | HUDSON RIVER FOODS CORP | Food | Product may be contaminated with Salmonella |
| Nov 19, 2025 | Alanwar Food Corp. | Food | Products found to contain leachable lead levels (0.323mg/L) |
| Nov 16, 2025 | Boss Dairy Farms | Food | Possible Listeria monocytogenes contamination. |
| Nov 14, 2025 | FRC INC | Food | FDA environmental sample identified the presence of Listeria monocytogenes in the processing area where cheese was packaged. |
| Nov 14, 2025 | Fresenius Kabi USA, LLC | Devices | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. |
| Nov 14, 2025 | GE Medical Systems China Co., Ltd. | Devices | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC… |
| Nov 14, 2025 | GE Medical Systems China Co., Ltd. | Devices | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC… |
| Nov 14, 2025 | GE Medical Systems China Co., Ltd. | Devices | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC… |
| Nov 13, 2025 | American Nuts, LLC | Food | Potential Salmonella contamination. |
| Nov 12, 2025 | Genepro Protein, Inc. | Food | Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen |
| Nov 12, 2025 | Stuffed Foods LLC | Food | Undeclared Soy Protein Concentrate |
| Nov 11, 2025 | AVID Medical, Inc. | Devices | Devices are not suitable for organ transplant. |
| Nov 11, 2025 | AVID Medical, Inc. | Devices | Devices are not suitable for organ transplant. |
| Nov 11, 2025 | AVID Medical, Inc. | Devices | Devices are not suitable for organ transplant. |
| Nov 11, 2025 | Lexunder Inc | Food | Contaminated with Salmonella |
| Nov 11, 2025 | Lexunder Inc | Food | Contaminated with Salmonella |
| Nov 10, 2025 | Draeger, Inc. | Devices | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| Nov 10, 2025 | Draeger, Inc. | Devices | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| Nov 10, 2025 | Draeger, Inc. | Devices | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| Nov 10, 2025 | Draeger, Inc. | Devices | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| Nov 8, 2025 | ByHeart, INC. | Food | Contaminated with Clostridium botulinum |
| Nov 7, 2025 | Anthony's BBQ | Food | Undeclared allergen (fish). Anthony's Barbecue & Dip-It Sauce label does not declare Worcestershire (Anchovy). |
| Nov 6, 2025 | Fresenius Kabi USA, LLC | Drugs | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. |
| Nov 5, 2025 | African Food On Wheels Inc. | Food | Clostridium botulinum (uneviscerated fish) |
| Nov 4, 2025 | Africa Imports | Food | Product tested positive for Salmonella. |
| Nov 4, 2025 | Tai Phat Wholesalers, LLC | Food | Undeclared sulfites |
| Nov 3, 2025 | Fresenius Kabi USA, LLC | Devices | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. |
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