FDA Warning Letters, 483s and Recalls: September 2026
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 29, 2026 | Baxter International Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 29, 2026 | Dreyer’S Grand Ice Cream, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 29, 2026 | IF Co-Pack, LLC Dba Initiative Foods | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated |
| Sep 29, 2026 | Psyched Wellness Ltd. | Human Foods Program | Dietary Supplement/Adulterated |
| Sep 28, 2026 | SnugZ USA, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 25, 2026 | Beaute Bounty | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations |
| Sep 24, 2026 | Cheap Medicine Shop/Www.Cheapmedicineshop.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded (Internet Pharmacy) |
| Sep 23, 2026 | Jiangmen Shuizirun Sanitary Articles Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 23, 2026 | Neogen Corporation | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 23, 2026 | Online Generic Medicine/Www.Onlinegenericmedicine.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug/Misbranded (Internet Pharmacy) |
| Sep 23, 2026 | Sciarra Aeromed, Inc. | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 22, 2026 | Datil Fresh Produce LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Sep 22, 2026 | Fresenius Kabi USA LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 22, 2026 | Rama Food Manufacture Corp. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Sep 22, 2026 | Unilam Co., LTD | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Sep 21, 2026 | Babikian Healthcare Products CJSC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 18, 2026 | Curia New York, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Sep 18, 2026 | Empower Clinic Services, LLC Dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Sep 17, 2026 | Bentley Laboratories LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Sep 14, 2026 | Celmade | Center for Drug Evaluation and Research (CDER) | Review of Website/Unapproved New Drug/Misbranded |
| Sep 14, 2026 | SCA Pharmaceuticals, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 11, 2026 | NexCell Scientific Inc | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations |
| Sep 11, 2026 | Ocean Pride Seafood, Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Sep 11, 2026 | RDM Express Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Sep 9, 2026 | Moda Food LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Sep 9, 2026 | Safi Pushcart Supplies Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Sep 8, 2026 | Kdc/One Chatsworth, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 4, 2026 | Bausch & Lomb Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 2, 2026 | TCI Co., Ltd BioCosme PABP BRANCH | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 1, 2026 | Happy Farm Botanicals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Sep 1, 2026 | O.N. Diagnostics, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded |
| Sep 1, 2026 | Star Ocean Wholesale Foods, Inc. | Office of Inspections and Investigations | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
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 22, 2026 | Adja Khady Food Distribution Inc | Food/Cosmetics | United States |
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 117.135(a)(1) | Sanitation preventive controls - Implement | 17 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 14 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 10 |
| 21 CFR 111.70(b) | Specifications - components | 9 |
| 21 CFR 117.35(c) | Pest control | 9 |
| ISO 13485:2016 Clause 8.2.2 | Lack of documented justification for not investigating complaint(s) | 9 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 8 |
| 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) | 7 |
| 21 CFR 117.20(b) | Plant construction and design | 7 |
| 21 CFR 123.6(b) | No HACCP plan | 7 |
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, 2026 | Gardeners Basics | Food | Salmonella |
| Sep 25, 2026 | Wild West Seed Inc | Food | Salmonella |
| Sep 24, 2026 | GIAS FOOD INC. | Food | Contamination with Listeria monocytogenes |
| Sep 24, 2026 | Philips Ultrasound, LLC | Devices | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular… |
| Sep 23, 2026 | DEANO'S PASTA | Food | Undeclared Lobster |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 17, 2026 | Ventec Life Systems, Inc. | Devices | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and… |
| Sep 14, 2026 | A&P CREATIONS | Food | Product contains undeclared Sildenafil and Tadalafil. |
| Sep 14, 2026 | A&P CREATIONS | Food | Product contains undeclared Sildenafil and Tadalafil. |
| Sep 12, 2026 | Berlin Seeds | Food | Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination. |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 11, 2026 | TODD'S SEEDS LLC | Food | Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) |
| Sep 8, 2026 | WFM Purchasing, LP | Food | Undeclared Egg Allergen |
| Sep 4, 2026 | Evergreen Fresh Sprouts LLC | Food | Salmonella |
| Sep 4, 2026 | LEASA Industries Co., Inc. | Food | Seeds may have been contaminated with E.coli |
| Sep 4, 2026 | LEASA Industries Co., Inc. | Food | Seeds may have been contaminated with E. coli |
| Sep 3, 2026 | Draeger, Inc. | Devices | Potential cracks in the hose, which could lead to leakage or the hose falling off. |
| Sep 3, 2026 | GIAS FOOD INC. | Food | Contamination with Listeria monocytogenes |
| Sep 3, 2026 | Instrumentation Laboratory | Devices | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| Sep 3, 2026 | Instrumentation Laboratory | Devices | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
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