FDA Warning Letters, 483s and Recalls: February 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 |
|---|---|---|---|
| Feb 28, 2025 | Shree Jaya Laboratories PVT. LTD. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Feb 26, 2025 | Granules India Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 26, 2025 | USApeptide.Com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| Feb 25, 2025 | AH USA Group Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Feb 25, 2025 | Linghai ZhanWang Biotechnology Co., Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Feb 25, 2025 | TKTX Numbing Cream USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/OTC |
| Feb 25, 2025 | TKTX Numb Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug and Misbranded/OTC |
| Feb 25, 2025 | TKTX Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/OTC |
| Feb 25, 2025 | TKTX USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded/OTC |
| Feb 24, 2025 | Aspen Pharmacare Holdings Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 21, 2025 | Next Science LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Feb 21, 2025 | Red Oak Instruments, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Feb 14, 2025 | Sperm Bank, Inc. Dba Fertility Center Of California | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Feb 13, 2025 | Zenzi Pharmaceutical Industries Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records |
| Feb 11, 2025 | Chem-Tech, Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
| Feb 10, 2025 | ABR Laboratory LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Feb 10, 2025 | Exer Labs, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Feb 10, 2025 | Marshalls Traditional Healthcare CC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Feb 7, 2025 | Aurora Pharmaceutical | Center for Veterinary Medicine | False & Misleading Claims/Misbranded |
| Feb 6, 2025 | Tyche Industries Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Feb 5, 2025 | Chengdu Innovation Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Feb 5, 2025 | Jagsonpal Pharmaceuticals Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated |
| Feb 5, 2025 | Q’Apel Medical, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Feb 4, 2025 | ISOThrive, Inc. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |
| Feb 4, 2025 | Wuhu Nuowei Chemistry Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Feb 3, 2025 | Chaohu Daxin Foodstuffs Co., Ltd. | Human Foods Program | Seafood HACCP/CGMP for Foods/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 |
|---|---|---|---|
| Feb 28, 2025 | Anhui Hanbon Daily Chemical Co., Ltd. | Drugs | China |
| Feb 28, 2025 | Ethos Emergency Preparedness, LLC | Devices | United States |
| Feb 28, 2025 | JM Seafood Distribution LLC | Food/Cosmetics | United States |
| Feb 28, 2025 | PALMETTO ISOTOPES, LLC | Drugs | United States |
| Feb 27, 2025 | ABBE Laboratories, Inc. | Drugs | United States |
| Feb 27, 2025 | Bausch & Lomb Incorporated | Drugs | United States |
| Feb 27, 2025 | Visgeneer, Inc. | Devices | Taiwan |
| Feb 26, 2025 | BioXtek LLC | Biologics | United States |
| Feb 24, 2025 | A2A INTEGRATED LOGISTIC INC | Drugs | United States |
| Feb 24, 2025 | Jalisco Fresh Produce, Inc. | Food/Cosmetics | United States |
| Feb 21, 2025 | Bad Drip Labs Inc. | Tobacco | United States |
| Feb 21, 2025 | Guangxi Wuzhou Changhong Food Co., Ltd. | Food/Cosmetics | China |
| Feb 21, 2025 | ICHIEI FOODS CO., LTD. | Food/Cosmetics | Japan |
| Feb 21, 2025 | Scratch KC, LLC | Food/Cosmetics | United States |
| Feb 21, 2025 | Somerset Therapeutics Private Limited | Drugs | India |
| Feb 20, 2025 | Alfred Louie Inc | Food/Cosmetics | United States |
| Feb 20, 2025 | Gussyup LLC | Drugs | United States |
| Feb 20, 2025 | KABANA SKIN CARE | Drugs | United States |
| Feb 20, 2025 | Miguel A. Mujica Baella M.D. | Drugs | United States |
| Feb 20, 2025 | Sewoon Medical Co., Ltd. | Devices | Korea (the Republic of) |
| Feb 20, 2025 | Sunset Tobacco Wholesale, Inc. | Tobacco | United States |
| Feb 19, 2025 | Gate Gourmet, Inc. | Food/Cosmetics | United States |
| Feb 19, 2025 | NuVida Medical LLC | Biologics | United States |
| Feb 18, 2025 | KEY FOODS CO. | Food/Cosmetics | United States |
| Feb 18, 2025 | King Pharmaceuticals LLC | Drugs | United States |
| Feb 18, 2025 | Medical Chemical Corporation | Drugs | United States |
| Feb 18, 2025 | MICROspecialties, LLC | Devices | United States |
| Feb 18, 2025 | Pacific Coast Produce, Inc. | Food/Cosmetics | United States |
| Feb 14, 2025 | DingMoo LLC | Food/Cosmetics | United States |
| Feb 14, 2025 | Glenmark Pharmaceuticals Limited | Drugs | India |
| Feb 14, 2025 | Laboratoires Druide Inc. | Drugs | Canada |
| Feb 14, 2025 | Mericon Industries Inc. | Drugs | United States |
| Feb 13, 2025 | Country Favor Inc | Food/Cosmetics | United States |
| Feb 13, 2025 | The Father's Table, LLC | Food/Cosmetics | United States |
| Feb 12, 2025 | Ocho Rios-Miami, Inc. | Food/Cosmetics | United States |
| Feb 11, 2025 | TRIBAL MEDICINAL | Food/Cosmetics | India |
| Feb 7, 2025 | EUROBREAD INC. | Food/Cosmetics | United States |
| Feb 7, 2025 | Hikal Limited | Veterinary | India |
| Feb 7, 2025 | Kaneko Sangyo Co., Ltd. | Food/Cosmetics | Japan |
| Feb 7, 2025 | Morasch Meats Inc | Veterinary | United States |
| Feb 7, 2025 | Morton Salt Inc | Drugs | United States |
| Feb 7, 2025 | Novo Nordisk Inc. | Drugs | United States |
| Feb 7, 2025 | Paonan Biotech Co Ltd | Devices | Taiwan |
| Feb 7, 2025 | Revive Rx LLC | Drugs | United States |
| Feb 6, 2025 | FT Distro Inc | Tobacco | United States |
| Feb 6, 2025 | Newalta Dairy LLC | Veterinary | United States |
| Feb 6, 2025 | Person & Covey Inc | Drugs | United States |
| Feb 6, 2025 | Pharmaplast S.A.E. | Drugs | Egypt |
| Feb 5, 2025 | Amore Produce, LLC | Food/Cosmetics | United States |
| Feb 5, 2025 | Ecigrusa LLC | Tobacco | United States |
| Feb 5, 2025 | InVia Fertility Specialists, PLLC | Biologics | United States |
| Feb 5, 2025 | NeuroSync, Inc. | Devices | United States |
| Feb 3, 2025 | Caledonia Farmers Elevator Company | Veterinary | 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) | FSVP assurances | 51 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 26 |
| 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard | 23 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 22 |
| 21 CFR 117.35(c) | Pest control | 22 |
| 21 CFR 211.192 | Written record of investigation incomplete | 17 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 16 |
| 21 CFR 1.506(b) | Supplier verification - follow written procedures | 15 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 15 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 15 |
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 |
|---|---|---|---|
| Feb 28, 2025 | LITTLE LEAF FARMS LLC | Food | Product may contain incorrect salad dressing, resulting in fish and wheat being undeclared. |
| Feb 27, 2025 | Tandem Diabetes Care, Inc. | Devices | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology… |
| Feb 27, 2025 | Tandem Diabetes Care, Inc. | Devices | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology… |
| Feb 26, 2025 | Covidien | Devices | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause… |
| Feb 26, 2025 | Qapel Medical Inc. | Devices | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and… |
| Feb 24, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | Lyons Magnus LLC | Food | Potential contamination with Listeria monocytogenes. |
| Feb 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures… |
| Feb 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures… |
| Feb 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medline medical procedure kits, containing Medtronic Aortic Root Cannula |
| Feb 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield | Devices | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures… |
| Feb 20, 2025 | Central Admixture Pharmacy Services, Inc. | Drugs | Presence of Particulate Matter |
| Feb 20, 2025 | One Source Nutrition, Inc, | Drugs | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. |
| Feb 19, 2025 | Calyxo, Inc. | Devices | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional… |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | AKT Trading Inc. | Food | Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label. |
| Feb 18, 2025 | CareFusion 303, Inc. | Devices | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| Feb 18, 2025 | CareFusion 303, Inc. | Devices | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| Feb 17, 2025 | Kenover Marketing Corp. | Food | Undeclared Allergen (Milk) |
| Feb 15, 2025 | NATURIPE VALUE ADDED FRESH LLC | Food | Incorrect back label on product resulting in undeclared allergens (wheat, eggs) |
| Feb 15, 2025 | ZB Importing LLC | Food | Undeclared wheat and egg |
| Feb 15, 2025 | ZB Importing LLC | Food | Undeclared egg |
| Feb 14, 2025 | CareFusion 213, LLC | Drugs | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. |
| Feb 14, 2025 | Mauna Loa Macadamia Nut Company, LLC | Food | Undeclared almonds |
| Feb 13, 2025 | ICU Medical, Inc. | Drugs | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium… |
| Feb 13, 2025 | ICU Medical, Inc. | Drugs | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap… |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may… |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 13, 2025 | Smiths Medical ASD, Inc. | Devices | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Feb 12, 2025 | JE Bakery 2019 LLC | Food | Undeclared allergen (walnuts) |
| Feb 7, 2025 | Jesse's Bakery, Inc. | Food | Undeclared Milk. |
| Feb 7, 2025 | Kedake Inc | Food | Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6. |
| Feb 6, 2025 | Jack & The Green Sprouts, Inc. | Food | Sprouts have the potential to be contaminated with Listeria monocytogenes |
| Feb 5, 2025 | Bard Peripheral Vascular Inc | Devices | Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events… |
| Feb 5, 2025 | Baxter Healthcare Corporation | Devices | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Feb 5, 2025 | Baxter Healthcare Corporation | Devices | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Feb 5, 2025 | Medtronic Perfusion Systems | Devices | Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to… |
| Feb 3, 2025 | Ventec Life Systems, Inc. | Devices | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an… |
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