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FDA Warning Letters, 483s and Recalls: January 2026

FDA enforcement records dated January 2026: 35 warning letters outside tobacco (plus 3 tobacco letters), 37 OAI inspections and 40 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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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.

DateCompanyIssuing officeSubject
Jan 30, 2026Cohance Lifesciences LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 29, 2026Central Coast Multispecialty Medical Group, Inc.Center for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jan 29, 2026Diasol, Inc.Center for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jan 29, 2026Fidelity Melon, IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jan 28, 2026Beta Bionics, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 28, 2026Beta Bionics, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 27, 2026Conceive Fertility CenterCenter for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jan 27, 2026Flextronics America LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 27, 2026HTO Nevada, Inc. Dba KirkmanCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 23, 2026Abbott Diabetes Care, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 23, 2026Intelligent Remedies, Inc.Human Foods ProgramNew Drug/Misbranded
Jan 23, 2026Louisville Reproductive CenterCenter for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jan 22, 2026Diamond-Herpanacine Of PA, Inc.Human Foods ProgramNew Drug/Misbranded
Jan 22, 2026South Bay Cold Storage & Handling, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 21, 2026Naumes, Inc.Human Foods ProgramFood/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jan 21, 2026Signature Formulations, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 21, 2026Supersmart USA, LLCHuman Foods ProgramNew Drug/Misbranded
Jan 20, 2026GenoGenix LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Jan 16, 2026Boothwyn Pharmacy, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Jan 16, 2026East CK Trading Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jan 16, 2026Feng Foods Trading Inc.Office of Inspections and InvestigationsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 16, 2026Zip Foods Importers, IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jan 15, 2026The Great Smart African Food LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jan 14, 2026Fulijaya Manufacturing SDN. BHD.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jan 14, 2026Min Jiang Food Store Inc Dba Koi Koi TradingHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jan 13, 2026Center For Immunology Science, LLCCenter for Drug Evaluation and Research (CDER)Sponsor/Investigator
Jan 9, 2026CC Pollen CompanyHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Jan 9, 2026Christopher Dale ButlerHuman Foods ProgramAcidified Foods/Emergency Permit Control/Adulterated
Jan 9, 2026GermaphobixCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jan 8, 2026Elanco Animal Health USACenter for Veterinary MedicineFalse & Misleading Claims/Misbranded
Jan 8, 2026GenetraceCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jan 8, 2026GenovateCenter for Biologics Evaluation and Research (CBER)Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Jan 8, 2026Prodrome Sciences USA, LLCCenter for Drug Evaluation and Research (CDER)Sponsor/Unapproved Misbranded
Jan 8, 2026Unomedical Device S.A. De C.V.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jan 7, 2026Winder Laboratories, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/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.

DateFacilityProduct typeCountry
Jan 30, 2026Element Materials Technology Oakland-ConcordDrugsUnited States
Jan 30, 2026Safrel Pharmaceuticals LLCDrugsUnited States
Jan 30, 2026Waves & Wine, Inc.VeterinaryUnited States
Jan 29, 2026Golden Dakota Farms, LLCVeterinaryUnited States
Jan 29, 2026Life Plus Style Gourmet LLCFood/CosmeticsUnited States
Jan 29, 2026Wakker Dairy Farm, LLCVeterinaryUnited States
Jan 28, 2026Hit Promotional Products Inc.DrugsUnited States
Jan 28, 2026Rancher's US OP LLCVeterinaryUnited States
Jan 27, 2026Centrient Pharmaceuticals India Private LimitedDrugsIndia
Jan 27, 2026Daily Manufacturing Solutions IncTobaccoUnited States
Jan 27, 2026TKS Co-Pack Manufacturing, LLCFood/CosmeticsUnited States
Jan 26, 2026Gold Land International Inc.Food/CosmeticsUnited States
Jan 26, 2026Spa De Soleil, Inc.DrugsUnited States
Jan 23, 2026Fuzhou Mintian Food Industry Park Co., LtdFood/CosmeticsChina
Jan 23, 2026Island Kinetics, Inc. D.B.A. CoValence LaboratoriesDrugsUnited States
Jan 23, 2026Shimoga ChemicalsDrugsIndia
Jan 22, 2026Excel VisionDrugsFrance
Jan 22, 2026Purcell InternationalFood/CosmeticsUnited States
Jan 22, 2026Raaw Energy, LLCVeterinaryUnited States
Jan 22, 2026Virbac CorporationVeterinaryUnited States
Jan 21, 2026Weihai Puyuan Food Co., Ltd.Food/CosmeticsChina
Jan 20, 2026Genzyme Ireland LimitedBiologicsIreland
Jan 20, 2026LINGHAM & SONS (MALAYSIA) SDN. BHD.Food/CosmeticsMalaysia
Jan 16, 2026ABS CorporationVeterinaryUnited States
Jan 16, 2026Dabur India LimitedDrugsIndia
Jan 16, 2026Lystn, LLCVeterinaryUnited States
Jan 16, 2026Marson Medical, Inc.DevicesUnited States
Jan 15, 2026Chunghae FoodFood/CosmeticsKorea (the Republic of)
Jan 15, 2026Danko Foods IncFood/CosmeticsUnited States
Jan 15, 2026FairyGene, Inc.DrugsUnited States
Jan 12, 2026H2 BEV, LLCFood/CosmeticsUnited States
Jan 12, 2026H2 RENU, INCFood/CosmeticsUnited States
Jan 12, 2026ZIIP INCDevicesUnited States
Jan 9, 2026City Market, Inc.Food/CosmeticsUnited States
Jan 8, 2026Lajuna, IncFood/CosmeticsUnited States
Jan 6, 2026OHOM PADMAAVATHII LLCFood/CosmeticsUnited States
Jan 2, 2026FIDELITY MELON INC.Food/CosmeticsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 117.35(a)Sanitary operations - Plant sanitation29
21 CFR 1.502(a)FSVP assurances27
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement23
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard17
21 CFR 117.35(c)Pest control15
21 CFR 111.70(b)Specifications - components14
21 CFR 117.10Personnel14
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls14
21 CFR 111.70(e)Specifications - finished dietary supplement13
21 CFR 123.6(b)No HACCP plan13

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Jan 31, 2026Costco Wholesale CorporationFoodUndeclared hazelnut.
Jan 30, 2026E & S Grocery & Bakery Inc.FoodUndeclared Egg Allergen
Jan 30, 2026Karns Prime And Fancy FoodsFoodProduct may contain undeclared peanuts.
Jan 30, 2026Reser's Fine Foods, Inc.FoodUndeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.
Jan 28, 2026AKKARCO LLCFoodUndeclared tadalafil
Jan 28, 2026Art Monkey LLC Dba Why Not NaturalFoodPotential to be contaminated with Salmonella
Jan 28, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADINGFoodUndeclared allergen ingredient (Wheat and Sesame)
Jan 28, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADINGFoodUndeclared allergen ingredient (Wheat and Sesame)
Jan 28, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADINGFoodUndeclared allergen ingredient (Wheat and Sesame)
Jan 27, 2026Abiomed, Inc.DevicesDifferential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Jan 27, 2026Abiomed, Inc.DevicesDifferential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Jan 27, 2026Abiomed, Inc.DevicesDifferential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Jan 23, 2026Navitas, LLC.FoodPotential contamination with Salmonella.
Jan 18, 2026Tradin Organics USA LLCFoodPotential contamination with Salmonella.
Jan 16, 2026McKessonDrugsTemperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature…
Jan 16, 2026Olympus Corporation Of The AmericasDevicesIssue with software algorithm which may lead to overpressure events.
Jan 16, 2026Olympus Corporation Of The AmericasDevicesIssue with software algorithm which may lead to overpressure events.
Jan 16, 2026Olympus Corporation Of The AmericasDevicesIssue with software algorithm which may lead to overpressure events.
Jan 15, 2026SUPERFOODS, INC.FoodProducts may be contaminated with Salmonella Typhimurium
Jan 15, 2026SUPERFOODS, INC.FoodProducts may be contaminated with Salmonella Typhimurium
Jan 9, 2026Modern Warrior Life, LLCFoodFDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination.
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination
Jan 9, 2026Spring & Mulberry Inc.FoodPotential Salmonella contamination.
Jan 8, 2026VH FOODS INCFoodUndeclared allergens: egg and milk
Jan 6, 2026Carrot Top Kitchens LLCFoodContains undeclared sesame
Jan 6, 2026Carrot Top Kitchens LLCFoodContains undeclared sesame
Jan 6, 2026Carrot Top Kitchens LLCFoodContains undeclared sesame
Jan 6, 2026Carrot Top Kitchens LLCFoodContains undeclared sesame
Jan 6, 2026Carrot Top Kitchens LLCFoodContains undeclared sesame
Jan 6, 2026Herbs ForeverFoodPotential undeclared allergen ingredient (Wheat)
Jan 6, 2026Herbs ForeverFoodPotential undeclared allergen ingredient (Wheat)

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.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.