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FDA Warning Letters, 483s and Recalls: May 2025

FDA enforcement records dated May 2025: 30 warning letters outside tobacco (plus 28 tobacco letters), 54 OAI inspections and 281 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
May 30, 2025Bio Wellness 444 LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
May 30, 2025Nefeteri WellnessOffice of Unapproved Drugs and Labeling ComplianceUnapproved New Drugs
May 29, 2025Amish Origins Management, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 29, 2025Laboratoire Druide Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 29, 2025Sprout Pharmaceuticals, Inc.The Office of Prescription Drug Promotion (OPDP)False & Misleading Claims/Misbranded
May 28, 2025Marin Baking LLCHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 28, 2025Voehlganic Farm LLCHuman Foods ProgramPHS Act/Shell Egg Regulation/Adulterated
May 27, 2025Grow Gold Land, Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
May 22, 2025Milo’S Poultry Farms, LLCHuman Foods ProgramPHS Act/Shell Egg Regulation/Adulterated
May 21, 2025Aju Pharm Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 20, 2025One Roof LLCHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
May 19, 2025CTK OTC Laboratories LLC Formerly FMK LABS, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 14, 2025Evi Labs LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 14, 2025Zhejiang Easyclean Daily Chemical Co., LtdCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 13, 2025AACE Pharmaceuticals, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 9, 2025Kabe Labortechnik GmbHCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 9, 2025NeuroSync, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 8, 2025FishMoxFishFlex/Simple Pet Health LLCCenter for Veterinary MedicineUnapproved New Animal Drug/Misbranded
May 8, 2025Microspecialties, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 8, 2025Product Society LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 7, 2025Excelvision FarevaCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 6, 2025DFI Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 6, 2025Shenzhen Hengkaifeng Commerce And Trade Co., LtdCenter for Drug Evaluation and Research (CDER)Failure to List/Misbranded
May 6, 2025Wailea Agricultural Group, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
May 5, 2025Sedecal S.A.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 5, 2025Staska Pharmaceuticals, Inc.Center for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
May 5, 2025Supreme Rejuvenation, LLCCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Misbranded
May 5, 2025Www.Buycodeine.UsCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
May 5, 2025Www.Peacefulmeds.ComCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
May 2, 2025San Juan Produce LLCOffice of Inspections and InvestigationsForeign 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.

DateFacilityProduct typeCountry
May 29, 2025LA VAPOR INCTobaccoUnited States
May 29, 2025Mexi-Land, Inc.Food/CosmeticsUnited States
May 29, 2025Ultimate Product Distributors LLCTobaccoUnited States
May 28, 2025A.D. BERRIES & MORE LLCFood/CosmeticsUnited States
May 28, 2025Gueldenkron Fruchtsaft GmbHFood/CosmeticsGermany
May 27, 2025August Egg CompanyFood/CosmeticsUnited States
May 27, 2025Coopertiva Vinicola Aurora LTDAFood/CosmeticsBrazil
May 23, 2025Medinatura New Mexico, Inc.DrugsUnited States
May 23, 2025Mexicorp LLCFood/CosmeticsUnited States
May 23, 2025Roots Organic FarmFood/CosmeticsUnited States
May 23, 2025Sklar BOV Solutions, IncDrugsUnited States
May 23, 2025Stokes Healthcare Inc.DrugsUnited States
May 23, 2025SV Labs Toronto CorporationDrugsCanada
May 23, 2025Tailstorm Health, IncDrugsUnited States
May 22, 2025Avadim Holdings IncDrugsUnited States
May 22, 2025GAGA PRO LIGHTING EQUIPMENT CO., LTD.DevicesChina
May 22, 2025SUPERCAN BULLY STICKS LLCVeterinaryUnited States
May 21, 2025Acino Products, LLCDrugsUnited States
May 21, 2025HOFOOD99 INC.Food/CosmeticsUnited States
May 21, 2025Miers Laboratories Ltd.DrugsNew Zealand
May 21, 2025Seema InternationalDrugsIndia
May 20, 2025Baylab USA, LLCDevicesUnited States
May 20, 2025Diamond-Herpanacine Of PA, Inc.Food/CosmeticsUnited States
May 19, 2025Smart ToothpicksTobaccoUnited States
May 16, 2025Bertrand P. Cole, D.O.DrugsUnited States
May 16, 2025Central Coast Multispecialty Medical Group, Inc.BiologicsUnited States
May 16, 2025Maui Seafood LLCFood/CosmeticsUnited States
May 16, 2025Reedhill Ventures LLCTobaccoUnited States
May 16, 2025VitaCare Labs Inc.DrugsCanada
May 16, 2025VPR CollectionTobaccoUnited States
May 15, 2025Apothecary Pharma LLCDrugsUnited States
May 15, 2025Rich Ice Cream Co.Food/CosmeticsUnited States
May 14, 2025Green Valley Fertility PartnersBiologicsUnited States
May 13, 2025Elba, Inc.DrugsUnited States
May 13, 2025Jose M. Carpio, M.D.DrugsUnited States
May 9, 2025Apotex Inc.DrugsCanada
May 9, 2025F & A FoundationDevicesUnited States
May 9, 2025Mukesh B. Chandre, MD MBBSDrugsIndia
May 9, 2025Smaart Medical Systems, IncDevicesUnited States
May 9, 2025Sparhawk Laboratories, Inc.VeterinaryUnited States
May 9, 2025World Perfumes Inc.DrugsUnited States
May 8, 2025Sabores Mexicanos Gourmet, S.A. De C.V.Food/CosmeticsMexico
May 7, 2025Steep Slope Vape SupplyTobaccoUnited States
May 6, 2025Ogle Cattle Company, Inc.VeterinaryUnited States
May 5, 2025DA BOMB LLCDrugsUnited States
May 5, 2025Nepa Wholesale, Inc.TobaccoUnited States
May 2, 2025Carolina Seafoods, Inc.Food/CosmeticsUnited States
May 2, 2025Focus Medical, LLCDevicesUnited States
May 2, 2025GPO Plus IncTobaccoUnited States
May 2, 2025Naturich Cosmetique LabsDrugsUnited States
May 2, 2025Scientific Protein Laboratories LLCDrugsUnited States
May 1, 2025Granja La CabanaFood/CosmeticsUnited States
May 1, 2025Performance Plus Marketing, Inc.TobaccoUnited States
May 1, 2025Robert G MillerFood/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 sanitation35
21 CFR 117.35(c)Pest control31
21 CFR 117.10Personnel30
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls28
21 CFR 1.502(a)FSVP assurances27
21 CFR 820.198(a)Lack of or inadequate complaint procedures22
21 CFR 111.70(e)Specifications - finished dietary supplement19
21 CFR 211.100(a)Approval and review of procedures19
21 CFR 111.70(b)Specifications - components18
21 CFR 820.100(a)Lack of or inadequate procedures18

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
May 30, 2025Baxter Healthcare CorporationDevicesThe Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories…
May 30, 2025Baxter Healthcare CorporationDevicesThe Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories…
May 30, 2025Maquet Critical Care ABDevicesPotential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect…
May 30, 2025Maquet Critical Care ABDevicesPotential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect…
May 30, 2025Maquet Critical Care ABDevicesPotential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect…
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025AND GO CONCEPTS DBA SALAD AND GOFoodPotential to be contaminated with Listeria monocytogenes
May 27, 2025Kilwin's Quality Confections, Inc.Foodundeclared pecans
May 27, 2025Kilwin's Quality Confections, Inc.Foodundeclared pecans
May 27, 2025Kilwin's Quality Confections, Inc.Foodundeclared pecans
May 27, 2025The Whole Herb Company, Inc.FoodPotential contamination with Salmonella.
May 24, 2025Santa Monica Seafood CompanyFoodAtlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)
May 23, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesLack of sterility assurance.
May 22, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesDevices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
May 22, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesDevices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
May 22, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesDevices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
May 21, 2025Albertsons Companies LLCFoodSalmonella. Greek Salad products were made with recalled cucumbers from Bedner Grower's Company which are contaminated with Salmonella and…
May 21, 2025Alex Kontos/Flavor-Pic Tomato CompanyFoodProduct has potential contamination with Salmonella
May 21, 2025Big Y SupermarketsFoodContains cucumber contaminated with Salmonella recalled by Bedner Growers Inc.
May 21, 2025CovidienDevicesVentilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either…
May 21, 2025Isabelle's Kitchen, Inc.FoodProduct has Salmonella contamination
May 21, 2025Isabelle's Kitchen, Inc.FoodProduct has Salmonella contamination
May 21, 2025Isabelle's Kitchen, Inc.FoodProduct has Salmonella contamination
May 21, 2025Isabelle's Kitchen, Inc.FoodProduct has Salmonella contamination
May 21, 2025Isabelle's Kitchen, Inc.FoodProduct has Salmonella contamination
May 21, 2025Reser's Fine Foods, Inc. Dba Fresh Creative FoodsFoodSalmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and…
May 21, 2025Sardilli Produce & Dairy Co. Inc.FoodContaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Sysco CorporationFoodCucumbers have the potential to be contaminated with Salmonella
May 21, 2025Ukrop's Homestyle Foods LLCFoodSalmonella. The firm received cucumbers produced by Bedner Farms.
May 21, 2025Umary-USA.ComDrugsMarketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and…
May 21, 2025Umary-USA.ComDrugsMarketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac…
May 20, 2025Chefs WarehouseFoodProduct is contaminated with Salmonella
May 20, 2025Chefs WarehouseFoodProduct is contaminated with Salmonella
May 20, 2025Chefs WarehouseFoodProduct is contaminated with Salmonella
May 20, 2025Chefs WarehouseFoodProduct is contaminated with Salmonella
May 20, 2025Chefs WarehouseFoodProduct is contaminated with Salmonella
May 20, 2025GBC Food Services, LLCFoodPotential to be contaminated with Salmonella
May 20, 2025GBC Food Services, LLCFoodPotential to be contaminated with Salmonella
May 20, 2025GBC Food Services, LLCFoodPotential to be contaminated with Salmonella
May 20, 2025GBC Food Services, LLCFoodPotential to be contaminated with Salmonella
May 20, 2025GBC Food Services, LLCFoodPotential to be contaminated with Salmonella
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.
May 20, 2025Harris TeeterFoodSalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi.

Showing the latest 100 of 281.

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