FDA Warning Letters, 483s and Recalls: March 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 |
|---|---|---|---|
| Mar 31, 2025 | DRG Instruments GmbH | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Mar 28, 2025 | Everything Sprouts, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 28, 2025 | Mother Earth Minerals, Inc. | Human Foods Program | Unapproved New Drugs/Misbranded |
| Mar 28, 2025 | Prodose, Inc. Formerly Known As Spirit Pharmaceuticals LLC | Center for Drug Evaluation and Research (CDER) | Electronic Drug Registration and Listing System (eDRLS)/Violations |
| Mar 27, 2025 | Www.Thesafepills.Org | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 27, 2025 | Yiling Pharmaceutical Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 26, 2025 | Naturista Store LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 25, 2025 | Americo F. Padilla, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Mar 25, 2025 | Amy Lightner, MD | Center for Biologics Evaluation and Research | Bioresearch Monitoring Program |
| Mar 25, 2025 | BioAsia Worldwide Sdn Bhd | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 25, 2025 | Latro Inc. | Human Foods Program | Adulterated Human Foods/Misbranded |
| Mar 24, 2025 | Huangshi Hygienic Material Medicine Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 24, 2025 | United Health Products, Inc. | Center for Devices and Radiological Health | Bioresearch Monitoring Program/Institutional Review Board (IRB) |
| Mar 21, 2025 | EpiCare Acquisitions, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Mar 20, 2025 | BPI Labs, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 19, 2025 | Jack & The Green Sprouts, Inc. | Human Foods Program | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
| Mar 14, 2025 | Advanced Pharmaceutical Technology | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Mar 14, 2025 | Country Favor Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 12, 2025 | CoLabs Intl. Corp | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/OTC |
| Mar 12, 2025 | Kabana Skin Care | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/OTC |
| Mar 12, 2025 | Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Mar 12, 2025 | Rex Implants Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Mar 12, 2025 | Waxhead Sun Defense Company | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| Mar 12, 2025 | Yangzhou Sion Commodity Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/API/Adulterated |
| Mar 10, 2025 | International Laboratories Corp | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Mar 10, 2025 | MG Infusions | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
| Mar 7, 2025 | United King Foods Private Limited | Human Foods Program | Low Acid Canned Food Regulation/Adulterated |
| Mar 6, 2025 | Pico IV Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 5, 2025 | Annovex Pharma, Inc. | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Mar 5, 2025 | Aspen Biopharma Labs Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Mar 5, 2025 | Macsen Drugs | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Mar 5, 2025 | Mehran Michael Bahrami, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Mar 5, 2025 | Zacanta LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Mar 4, 2025 | C & A Naturistics | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 4, 2025 | Dexcom, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Mar 4, 2025 | ProRx, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |
| Mar 3, 2025 | Amazon.Com, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2025 | Filler Lux Dba Filler Lux USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2025 | Fox Pharma LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2025 | Gonzar Produce, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Mar 3, 2025 | Hyaluron Pen Store, LLC Dba Glow Nest Beauty | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2025 | Julian Naya Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Mar 3, 2025 | Vivid-Scientific LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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 |
|---|---|---|---|
| Mar 31, 2025 | Amicogen (China) Biopharm Co., Ltd. | Veterinary | China |
| Mar 28, 2025 | Acme United Corporation | Drugs | United States |
| Mar 28, 2025 | APIPHARMA D.O.O | Drugs | Croatia |
| Mar 28, 2025 | Wells Pharma Of Houston LLC | Drugs | United States |
| Mar 28, 2025 | Xtend-Life Group Limited | Food/Cosmetics | New Zealand |
| Mar 27, 2025 | Apollo Care, LLC | Drugs | United States |
| Mar 27, 2025 | Bravo Packing, Inc. | Veterinary | United States |
| Mar 27, 2025 | HARBOR MARINE PRODUCT, INC. | Food/Cosmetics | United States |
| Mar 27, 2025 | Owen Biosciences Inc. | Drugs | United States |
| Mar 26, 2025 | BRS Analytical Services, LLC | Drugs | United States |
| Mar 26, 2025 | Fuller Industries Inc | Drugs | United States |
| Mar 26, 2025 | Seniorlife Technologies Inc | Devices | United States |
| Mar 26, 2025 | Sheng Kee Of California, Inc | Food/Cosmetics | United States |
| Mar 25, 2025 | Creative Essences Inc | Drugs | United States |
| Mar 25, 2025 | RDM Express Inc. | Food/Cosmetics | United States |
| Mar 25, 2025 | San Juan Produce, LLC | Food/Cosmetics | United States |
| Mar 24, 2025 | Delicias Del Contry Usa Inc | Food/Cosmetics | United States |
| Mar 21, 2025 | Fu Shing Preserved Vegetables Store | Food/Cosmetics | Taiwan |
| Mar 21, 2025 | Guangxi Yulin Pharmaceutical Group Co. Ltd. | Drugs | China |
| Mar 21, 2025 | La Parcela Produce LLC | Food/Cosmetics | United States |
| Mar 21, 2025 | Lavet Kft. | Veterinary | Hungary |
| Mar 21, 2025 | Steric Trading Pty Ltd | Food/Cosmetics | Australia |
| Mar 20, 2025 | Daddy's Vapor Distro, Inc. | Tobacco | United States |
| Mar 20, 2025 | Lanzhou Foci Pharmaceutical Co., Ltd. | Food/Cosmetics | China |
| Mar 20, 2025 | Sourav K. Mishra, M.D. | Drugs | India |
| Mar 20, 2025 | Tan Nam Corporation | Food/Cosmetics | United States |
| Mar 19, 2025 | Iacofano Group LLC | Food/Cosmetics | United States |
| Mar 19, 2025 | LYU YUAN PASTURE CO LTD | Food/Cosmetics | Taiwan |
| Mar 18, 2025 | Longford Water Company LLC | Food/Cosmetics | United States |
| Mar 14, 2025 | Acuity Specialty Products, Inc. | Drugs | United States |
| Mar 14, 2025 | Con. I. Ioannidis S.A. | Food/Cosmetics | Greece |
| Mar 14, 2025 | KVK Tech, Inc. | Drugs | United States |
| Mar 14, 2025 | Libby Laboratories, Inc. | Drugs | United States |
| Mar 14, 2025 | Taizhou Kangping Medical Science And Technology Co., Ltd. | Drugs | China |
| Mar 13, 2025 | Bio Protech Yantai Inc. | Devices | China |
| Mar 13, 2025 | Frenchman Valley Farmers Cooperative, Inc. | Veterinary | United States |
| Mar 13, 2025 | Hacienda Mexican Foods | Food/Cosmetics | United States |
| Mar 13, 2025 | Namil General Foods Co. | Food/Cosmetics | Korea (the Republic of) |
| Mar 13, 2025 | Naseem A. Jaffrani, M.D. | Drugs | United States |
| Mar 13, 2025 | Philips Ultrasound, Inc | Devices | United States |
| Mar 12, 2025 | LXR Biotech | Food/Cosmetics | United States |
| Mar 11, 2025 | Avertix Medical, Inc. | Devices | United States |
| Mar 11, 2025 | Dixon Investments Inc | Drugs | United States |
| Mar 11, 2025 | Mexican Villa Food Products Inc | Food/Cosmetics | United States |
| Mar 10, 2025 | Elwood International, Inc. | Food/Cosmetics | United States |
| Mar 7, 2025 | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | Drugs | China |
| Mar 7, 2025 | PARPARAS S.A. DIMITRA | Food/Cosmetics | Greece |
| Mar 7, 2025 | Peak Performance Nutrients, Inc. | Veterinary | United States |
| Mar 7, 2025 | Pratik Doshi, M.D. | Drugs | India |
| Mar 7, 2025 | Wisconsin Pharmacal Company | Drugs | United States |
| Mar 6, 2025 | Leltek Inc. | Devices | Taiwan |
| Mar 6, 2025 | Maria A. Carballosa MD | Drugs | United States |
| Mar 6, 2025 | Noble Pharma, LLC | Veterinary | United States |
| Mar 6, 2025 | Sterling Distributors | Drugs | United States |
| Mar 5, 2025 | Chromatography Institute Of America | Veterinary | United States |
| Mar 4, 2025 | Kutol Products Company, Inc. | Drugs | United States |
| Mar 4, 2025 | Uriel Pharmacy, Inc | Drugs | 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 1.502(a) | Develop FSVP | 51 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 28 |
| 21 CFR 117.35(c) | Pest control | 27 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 23 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 23 |
| 21 CFR 117.10 | Personnel | 20 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 20 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 20 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 20 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 18 |
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 |
|---|---|---|---|
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Knockroe Inc | Food | Undeclared Almonds |
| Mar 29, 2025 | Reser's Fine Foods, Inc. | Food | Undeclared peanuts, soy, sesame, and wheat. |
| Mar 28, 2025 | Walker's Fruit Basket And Press House | Food | May be contaminated with Clostridium botulinum |
| Mar 27, 2025 | Bausch & Lomb Surgical, Inc. | Devices | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire… |
| Mar 27, 2025 | Bausch & Lomb Surgical, Inc. | Devices | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire… |
| Mar 27, 2025 | Cromer Food Services, Inc | Food | Undeclared Milk - During an FDA inspection the firm was notified that milk was not declared on the label. |
| Mar 26, 2025 | Frito-Lay, Inc. Headquarters | Food | Undeclared allergen (milk). |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 21, 2025 | GE Medical Systems China Co., Ltd. | Devices | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control… |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 19, 2025 | Avanos Medical, Inc. | Devices | Lack of sterility assurance for closed suction catheter systems |
| Mar 14, 2025 | HAR Maspeth Corp. | Food | Contains undeclared egg |
| Mar 13, 2025 | Dr. Reddy's Laboratories, Inc. | Drugs | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while… |
| Mar 13, 2025 | Thoratec LLC | Devices | Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut… |
| Mar 12, 2025 | Conavi Medical Inc. | Devices | Due to manufacturing issues there is a potential for the catheter sheath to detach. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 12, 2025 | Draeger, Inc. | Devices | The potential for cracks forming in the breathing circuit hose. |
| Mar 11, 2025 | Bard Access Systems, Inc. | Devices | Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification… |
| Mar 11, 2025 | C.H. Guenther & Son LLC | Food | Undeclared allergen (eggs) and pork |
| Mar 11, 2025 | New Age International, Inc. | Food | Contaminated with Listeria monocytogenes |
| Mar 10, 2025 | NEW YORK WHOLESALE GROUP | Food | Products contain elevated levels of Lead (Pb): 3.688 ppm |
| Mar 10, 2025 | NEW YORK WHOLESALE GROUP | Food | Products contain elevated levels of Lead (Pb): 6.504 ppm |
| Mar 10, 2025 | NEW YORK WHOLESALE GROUP | Food | Products contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm; |
| Mar 10, 2025 | NEW YORK WHOLESALE GROUP | Food | Products contain elevated levels of Lead (Pb): 88.038 ppm |
| Mar 4, 2025 | Liaoning Cheng Da (USA) Inc | Food | (Imported) Hot Pot Sauce (SPICY) contains undeclared allergens (Wheat and Soy) |
| Mar 4, 2025 | Liaoning Cheng Da (USA) Inc | Food | (Imported) Hot Pot Sauce contains undeclared allergens (Wheat and Soy) |
| Mar 4, 2025 | ZOLL Circulation, Inc. | Devices | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. |
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