Home / Months / December 2025

FDA Warning Letters, 483s and Recalls: December 2025

FDA enforcement records dated December 2025: 56 warning letters outside tobacco (plus 8 tobacco letters), 28 OAI inspections and 37 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
Dec 30, 2025Absolutely NaturalCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 30, 2025R.R. Importaciones Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Dec 23, 2025Chemspec Chemicals Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Dec 23, 2025LXR Biotech, LLCHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Dec 23, 2025Tower Laboratories Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 22, 2025Meridian Bioscience, IncCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 22, 2025Purushothaman Damodara Kumaran, M.D.Center for Drug Evaluation and Research (CDER)In Vivo Bioavailability-Bioequivalence Studies – Clinical
Dec 19, 2025Agebox Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drug/Misbranded
Dec 19, 2025Exactech, Inc. Dba Advita OrthoCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 19, 2025LiquidCapsule Manufacturing, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 19, 2025Unipack LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 18, 2025Private Label Skin Care, Inc.Center for Drug Evaluation and Research (CDER)CGMP/OTC/Adulterated/Misbranded
Dec 18, 2025RSV Pita, Inc. DBA Pita Pan BakeryHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Dec 17, 2025MAST Biosurgery USA, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 16, 2025Early To Bed, Inc.Center for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025FLAVNT Streetwear, LLCCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025Flux Lab Pte. Ltd. D/B/A The FluxionCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025For Them, Inc.Center for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025GenderBender LLCCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025Guangdong Renhe Guozhuang Biotechnology Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 16, 2025Marli Washington Design, LLCCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025Philadelphia 7, Inc D/B/A Passional BoutiqueCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025ShapeShifter Apparel, LLCCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025TG Supply LLC D/B/A TransGuy SupplyCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025TomboyX, PBCCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025TOMSCOUTCenter for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 16, 2025Trans-Missie B.V.Center for Devices and Radiological HealthFailure to Register and List/Misbranded
Dec 15, 2025Integrity Partners GroupCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 12, 2025Atomix LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Dec 12, 2025Dynamic Health Group Dba SARMS AMERICACenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Dec 12, 2025Maria A. Carballosa, M.D.Center for Drug Evaluation and Research (CDER)In Vivo Bioavailability-Bioequivalence Studies – Clinical
Dec 12, 2025MedisourceRxCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Dec 12, 2025Musclepower Enterprise Ltd. Dba MONSTER KING And GE LABSCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Dec 12, 2025Pinnacle Professional Research Dba Pinnacle PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Dec 12, 2025Prime Sports NutritionCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Dec 12, 2025Target CorporationHuman Foods ProgramInfant Botulism Outbreak
Dec 12, 2025The Albertsons Companies IncorporatedHuman Foods ProgramInfant Botulism Outbreak
Dec 12, 2025The Kroger CompanyHuman Foods ProgramInfant Botulism Outbreak
Dec 12, 2025TITAN SARMS LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Dec 12, 2025Walmart, Inc.Human Foods ProgramInfant Botulism Outbreak
Dec 11, 2025Devalingam Mahalingam, M.D., Ph.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
Dec 11, 2025Palamur Biosciences Private LimitedCenter for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Dec 10, 2025Maui Seafood LLCHuman Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Dec 10, 2025Medinatura New Mexico, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 9, 2025ASP Global, LLC. Dba Anatomy Supply Partners, LLC.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Dec 9, 2025Sklar Personal Care Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Dec 9, 2025SV Labs CorporationCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/Adulterated
Dec 8, 2025Darmerica, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Dec 4, 20253D Imaging Drug Design And Development LLCCenter for Drug Evaluation and Research (CDER)CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
Dec 4, 2025King FarmCenter for Veterinary MedicineCGMP/Animal Food/Adulterated
Dec 3, 2025Green Valley Fertility PartnersCenter for Biologics Evaluation and Research (CBER)Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dec 3, 2025Microvascular Tissue, Inc.Center for Biologics Evaluation and Research (CBER)CGMP/Deviations/Biologics License Application (BLA)
Dec 1, 2025Apothecary Pharma, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Dec 1, 2025BioXtek LLCOffice of Compliance and Biologics QualityUnapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Dec 1, 2025Celularity, IncOffice of Compliance and Biologics QualityUnapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Dec 1, 2025Seaway Pharma Inc.Office of Manufacturing QualityCGMP/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
Dec 31, 2025Peter Schiff EnterprisesDevicesUnited States
Dec 23, 2025Smithfield Bioscience IncDrugsUnited States
Dec 22, 2025Blaine Labs IncDrugsUnited States
Dec 19, 2025International Medication Systems Ltd.DrugsUnited States
Dec 19, 2025Laboratorios Jaloma S.A. De C.V.DrugsMexico
Dec 19, 2025Schlechter Farms IncFood/CosmeticsUnited States
Dec 18, 2025DiAgam Societe Anonyme (S.A.)DevicesBelgium
Dec 18, 2025JX Restaurants, Inc.Food/CosmeticsUnited States
Dec 18, 2025Meta Labs Pharmaceuticals, LLCFood/CosmeticsUnited States
Dec 17, 2025Macau-Union Pharmaceutical LimitedDrugsMacao
Dec 16, 2025Bello Bio LLCBiologicsUnited States
Dec 16, 2025Regen Suppliers LLCBiologicsUnited States
Dec 16, 2025The Great Smart African Food LLCFood/CosmeticsUnited States
Dec 12, 2025Black Diamond Video Inc.DevicesUnited States
Dec 12, 2025Marin Baking LLCFood/CosmeticsUnited States
Dec 12, 2025SMS Pharmaceuticals LimitedDrugsIndia
Dec 12, 2025Wellmill, LLCFood/CosmeticsUnited States
Dec 11, 2025Specialty Health Products CO, LLCDevicesUnited States
Dec 10, 20253B Medical, Inc.DevicesUnited States
Dec 10, 2025Next Medical Products Company, LLCDevicesUnited States
Dec 10, 2025Wizcure Pharmaa Private LimitedDrugsIndia
Dec 8, 2025Global Tobacco LLCTobaccoUnited States
Dec 5, 2025J.M. Huber Micropowders, IncDrugsUnited States
Dec 4, 2025Alchymars ICM SM Private LimitedDrugsIndia
Dec 4, 2025David Rosen Bakery Supplies Company, Inc.Food/CosmeticsUnited States
Dec 3, 2025ASEPTIKITS, LLCDevicesUnited States
Dec 3, 2025DAEWANG CO.,LTD.Food/CosmeticsKorea (the Republic of)
Dec 3, 2025Jalisco Fresh Produce, 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 sanitation24
21 CFR 1.502(a)FSVP assurances23
21 CFR 820.100(a)Lack of or inadequate procedures21
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard19
21 CFR 820.198(a)Lack of or inadequate complaint procedures19
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement16
21 CFR 117.35(c)Pest control13
21 CFR 1.506(e)(1)Verification activity before import, periodically12
21 CFR 117.10Personnel10
21 CFR 123.6(b)No HACCP plan10

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
Dec 31, 2025WFM Purchasing, LPFoodUndeclared Fish and Egg Allergen
Dec 29, 2025WHILL, INC.DevicesCyber vulnerability of BLE communication was found by CISA VDP program.
Dec 29, 2025WHILL, INC.DevicesCyber vulnerability of BLE communication was found by CISA VDP program.
Dec 23, 2025B.C. Williams Bakery Service, IncFoodUndeclared Milk Allergen
Dec 23, 2025B.C. Williams Bakery Service, IncFoodUndeclared Milk Allergen
Dec 23, 2025B.C. Williams Bakery Service, IncFoodUndeclared Milk Allergen
Dec 22, 2025HANDELNINE GLOBAL LLCDrugsCGMP Deviations: product found to contain lead.
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 22, 2025Medline Industries, LPDevicesThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of…
Dec 21, 2025One Roof LLCFoodUndeclared tree nut allergens: almonds, pecans, and walnuts.
Dec 20, 2025Fran's Chocolates LtdFoodundeclared hazelnut.
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Boston Scientific CorporationDevicesIncreased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty…
Dec 19, 2025Gregory's Foods, IncFoodUndeclared peanuts.
Dec 19, 2025Troemner FarmFoodundeclared soy, wheat, milk
Dec 15, 2025StuffbyNainaxDrugsMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Dec 15, 2025SunMed Holdings, LLCDevicesProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Dec 15, 2025SunMed Holdings, LLCDevicesProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Dec 15, 2025SunMed Holdings, LLCDevicesProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Dec 15, 2025SunMed Holdings, LLCDevicesProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Dec 12, 2025Medinatura New Mexico, Inc.DrugsMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified…
Dec 12, 2025Medinatura New Mexico, Inc.DrugsMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified…
Dec 12, 2025South Asian Food Inc.FoodContains undeclared peanuts
Dec 10, 2025White Castle SystemFoodUndeclared allergens (milk and soy).
Dec 8, 2025Sam Dry Fruits And Nuts Enterprises, IncFoodPotential contamination with Salmonella.
Dec 4, 2025Organic Living Superfoods LlcFoodProducts may be contaminated with Salmonella Richmond.
Dec 3, 2025Lund Food Holdings IncFoodUndeclared allergens (Peanut, Egg, Soy)
Dec 2, 2025Mellace Family Brands California IncFoodPotential contamination with Salmonella

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.