FDA Warning Letters, 483s and Recalls: June 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 |
|---|---|---|---|
| Jun 29, 2026 | Balkanica LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 26, 2026 | Shouly Import Corp. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 25, 2026 | Excelvision - Fareva | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 24, 2026 | Win Woo Trading, LLC / HF Foods Group | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 24, 2026 | Wizcure Pharmaa Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 23, 2026 | Allandale Dairy | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Jun 23, 2026 | All Ketamine HCL / Www.Allketaminehcl.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Buy Keta Online / Www.Buyketaonline.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Extra Medication / Www.Extramedication.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ketacyn Pharmaceuticals / Www.Ketacynpharma.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Keta Med Lab / Www.Ketamedlab.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ketamine Store / Www.Ketaminestore.Org | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ketaminetroches.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ketamine Troche Store / Www.Ketaminetrochestore.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ketdaxandrugs / Www.Ketdaxandrugs.Org | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Ket Plug / Ketaminelab.Org And Buyketaminepowderonline.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Legit Ketamine Suppliers / Www.Legitketaminesuppliers.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | LyfeUnit / Www.Lyfeunit.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Med Shop Inc / Www.Medshopinc.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 23, 2026 | Pure Arylcyclohexylamine Store / Www.Arylcyclohexylamine.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 22, 2026 | Genzyme Ireland Limited | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
| Jun 17, 2026 | Amazon.Com, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Great India Overseas Pvt. Ltd. Dba Silkrute | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Jun 17, 2026 | Hadassah Healing Oils Ltd | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| Jun 17, 2026 | Herbal Dermals LLC FZ Dba Gotucream | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Indiangoods.Shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | JJLBRO | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Leading Edge Health Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | MantroForce | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Telos Trading Limited Dba Alwinshop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Texinkart Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Wholesale Peptide | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 17, 2026 | Wild Arabic Herbs | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Jun 16, 2026 | Diamond Distributions LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 16, 2026 | Tex-Stein Dairy | Center for Veterinary Medicine | New Animal Drug/Adulterated |
| Jun 15, 2026 | Happiest Baby, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Jun 15, 2026 | Huons Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 15, 2026 | Life & Food Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 15, 2026 | Yangzhou Hongshengding Chemical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records |
| Jun 12, 2026 | AHC Products, Inc. | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 12, 2026 | Nihon Kohden Digital Health Solutions, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Jun 8, 2026 | Altru Telehealth, LLC Dba Altru Telehealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Amie Health, Inc. Dba Amie | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Clover Meds LLC Dba Clover Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Delight Distribution Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 8, 2026 | D&H Medical Services | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Eden Health International Inc. Dba Eden | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Ezra Holdco LLC Dba Ezra | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | FITISH | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | FitRX, LLC Dba AM RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Glow Medispa, LLC Dba Mint Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | HydraMed IV LLC Dba HydraMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Joi And Blokes Dba Joi + Blokes | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Maximus Health, Inc. Dba Maximus | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Medica Weight Loss | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Momentum Health 360 Dba Momentum Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | NativeMed LLC Dba NativeMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Nexlife Inc. Dba Nexlife | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Nexus Health Solutions LLC Dba Harper Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Nova Vascular LLC Dba NOVARX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | OrderlyMeds LLC Dba OrderlyMeds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Public Health Solution LLC Dba DrMedHealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Ready Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Roen Health, Inc. Dba RoenRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Thrivelab Co. Dba Thrivelab | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Trinity HealthCare Supply, LLC Dba altRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | VivioMD Group LLC Dba VivioMD | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
| Jun 8, 2026 | Vivot LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 8, 2026 | YS Group Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 5, 2026 | Imu-Tek Animal Health, Incorporated | Human Foods Program | Dietary Supplement/New Drug/Misbranded |
| Jun 5, 2026 | Mineral BioSciences, LLC | Human Foods Program | Unapproved New Drugs/Misbranded |
| Jun 5, 2026 | Sante Manufacturing Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 4, 2026 | AseptiKits, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Jun 4, 2026 | Nutratech, LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Jun 3, 2026 | BlephEx, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Jun 3, 2026 | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Jun 3, 2026 | InvaDerm, Inc. | Center for Drug Evaluation and Research (CDER) | Electronic Drug Registration and Listing System (eDRLS)/Violations |
| Jun 2, 2026 | Asanuma Corporation - Sagamihara Factory | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Erkul Kozmetik Sanayi Ve Ticaret A.S. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Gopaldas Visram & Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Laboratorios Dr. Collado S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | M G R Produce LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 2, 2026 | PLZ Corp | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Revlon Group Holdings, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Shantou Qiwei Industry Co., LTD | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | SL Follen Company | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Jun 2, 2026 | Umendra Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |
| Jun 2, 2026 | Zydus Lifesciences Limited | Center for Drug Evaluation and Research (CDER) | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated |
| Jun 1, 2026 | Yam Man Foods LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
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 |
|---|---|---|---|
| Jun 26, 2026 | Advanced Cosmetic Research Laboratories, Inc. | Drugs | United States |
| Jun 26, 2026 | GANESH PROPERTIES LLC | Food/Cosmetics | United States |
| Jun 26, 2026 | Natural Essentials Incorporated | Drugs | United States |
| Jun 26, 2026 | Shandong Anhong Pharmaceutical Co., Ltd. | Drugs | China |
| Jun 26, 2026 | S.S.S. Company (International) | Drugs | United States |
| Jun 24, 2026 | ZORRY PRODUCE CORP | Food/Cosmetics | United States |
| Jun 23, 2026 | Mi Bodeguita Del Valle LLC | Food/Cosmetics | United States |
| Jun 23, 2026 | Scinopharm Taiwan, Ltd. | Drugs | Taiwan |
| Jun 19, 2026 | Nowcos Co., Ltd. | Drugs | Korea (the Republic of) |
| Jun 18, 2026 | ENGENEIC PTY | Drugs | Australia |
| Jun 17, 2026 | University Of Illinois Poultry Research Farm | Food/Cosmetics | United States |
| Jun 16, 2026 | John & Nicole Santos Dairy | Veterinary | United States |
| Jun 12, 2026 | Nikken Medical Corporation | Food/Cosmetics | Japan |
| Jun 12, 2026 | Product Society LLC | Drugs | United States |
| Jun 12, 2026 | The Flower Remedy LLC | Drugs | United States |
| Jun 9, 2026 | The Procter & Gamble Manufacturing Company | Drugs | United States |
| Jun 9, 2026 | Umicore Argentina S.A. | Drugs | Argentina |
| Jun 6, 2026 | PRITAM INTERNATIONAL PRIVATE LIMITED | Drugs | India |
| Jun 4, 2026 | Fil-Bay Import, Inc. | Food/Cosmetics | United States |
| Jun 4, 2026 | Piquin Y Sabores Distributors LLC | Food/Cosmetics | United States |
| Jun 3, 2026 | Eurofins SF Analytical Laboratories, 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 | 42 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 33 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 31 |
| 21 CFR 111.70(b) | Specifications - components | 22 |
| 21 CFR 123.6(b) | No HACCP plan | 21 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 20 |
| ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization | 20 |
| 21 CFR 111.70(e) | Specifications - finished dietary supplement | 19 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 18 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 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 |
|---|---|---|---|
| Jun 30, 2026 | Baxter Healthcare Corporation | Devices | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed… |
| Jun 26, 2026 | Total Nutrition Inc | Food | Contaminated with Salmonella |
| Jun 25, 2026 | Fresh & Ready Foods LLC | Food | Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken… |
| Jun 25, 2026 | Fresh & Ready Foods LLC | Food | Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a… |
| Jun 25, 2026 | GELLERT GLOBAL GROUP | Food | Undeclared Allergen (Fish) |
| Jun 25, 2026 | Publix Super Markets, Inc. | Food | Due to potential E. coli O145:H28 contamination |
| Jun 25, 2026 | Publix Super Markets, Inc. | Food | Due to potential E. coli O145:H28 contamination |
| Jun 25, 2026 | Publix Super Markets, Inc. | Food | Due to potential E. coli O145:H28 contamination |
| Jun 25, 2026 | Publix Super Markets, Inc. | Food | Due to potential E. coli O145:H28 contamination |
| Jun 25, 2026 | ResMed Ltd. | Devices | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state… |
| Jun 24, 2026 | JB Chemicals And Pharmaceuticals Ltd | Drugs | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine… |
| Jun 24, 2026 | Lehi Valley Trading Company, Inc | Food | Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging. |
| Jun 24, 2026 | Trafa Pharmaceutical Inc. | Food | Potential contamination with Salmonella |
| Jun 17, 2026 | Boston Scientific Neuromodulation Corporation | Devices | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or… |
| Jun 15, 2026 | Western Mixers Produce & Nuts, Inc. | Food | Undeclared peanuts. |
| Jun 13, 2026 | NARA ORGANICS INC | Food | Product may be contaminated with Clostridium botulinum. |
| Jun 12, 2026 | Adams Extract & Spice LLC | Food | Undeclared Sesame allergen |
| Jun 12, 2026 | Adams Extract & Spice LLC | Food | Undeclared Sesame allergen |
| Jun 12, 2026 | Adams Extract & Spice LLC | Food | Undeclared Sesame allergen |
| Jun 12, 2026 | Adams Extract & Spice LLC | Food | Undeclared Sesame allergen |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 11, 2026 | Abiomed, Inc. | Devices | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers… |
| Jun 10, 2026 | Oscor Inc. | Devices | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap… |
| Jun 10, 2026 | Oscor Inc. | Devices | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap… |
| Jun 10, 2026 | Oscor Inc. | Devices | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap… |
| Jun 9, 2026 | GREENWORLD FOOD EXPRESS (USA) LLC | Food | Product may be contaminated with Salmonella |
| Jun 8, 2026 | Medline Industries, LP | Devices | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which… |
| Jun 8, 2026 | Medline Industries, LP | Devices | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which… |
| Jun 5, 2026 | Medline Industries, LP | Devices | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine… |
| Jun 5, 2026 | Medline Industries, LP | Devices | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine… |
| Jun 5, 2026 | Medline Industries, LP | Devices | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine… |
| Jun 5, 2026 | Nelson & Isa Lacteos LLC | Food | Products may be contaminated with Listeria monocytogenes. |
| Jun 4, 2026 | Haleon US Holdings LLC | Drugs | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. |
| Jun 4, 2026 | La Colonia Foods Llc | Food | Products may be contaminated with Listeria monocytogenes. |
| Jun 4, 2026 | La Colonia Foods Llc | Food | Products may be contaminated with Listeria monocytogenes. |
| Jun 4, 2026 | La Colonia Foods Llc | Food | Products may be contaminated with Listeria monocytogenes. |
| Jun 4, 2026 | La Colonia Foods Llc | Food | Products may be contaminated with Listeria monocytogenes. |
| Jun 2, 2026 | Prime Food Processing LLC. | Food | Improperly eviscerated which may result in Clostridium botulinum contamination |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | Argon Medical Devices, Inc | Devices | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria… |
| Jun 1, 2026 | BEEKEEPER'S NATURALS USA INC. | Drugs | Microbial Contamination of Non-Sterile Products |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
| Jun 1, 2026 | Clover Hill Dairy, LLC | Food | Product contaminated with Listeria monocytogenes. |
Check one company
See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.