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FDA Warning Letters, 483s and Recalls: June 2025

FDA enforcement records dated June 2025: 37 warning letters outside tobacco (plus 16 tobacco letters), 58 OAI inspections and 61 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
Jun 27, 2025Libby Laboratories, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 27, 2025Mectronic Medicale S.R.L.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jun 26, 2025Mark J. Savant, M.DCenter for Drug Evaluation and Research (CDER)Clinical Investigator
Jun 25, 20257Tabz Retail, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs
Jun 25, 2025CCIC Huatongwei International Inspection Co., Ltd.Center for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jun 25, 2025Hydroxie, LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drug/Human Food/Adulterated
Jun 25, 2025My Smoke WholesaleHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Jun 25, 2025Nature’S Fusions LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 25, 2025Relax Relief Rejuvenate Trading, LLC Dba RRR Trading Or EDP KratomHuman Foods ProgramDietary Supplement/Adulterated
Jun 25, 2025Royal Diamond Imports, Inc.Human Foods ProgramUnapproved New Drug/Misbranded
Jun 25, 2025Shaman Botanicals, LLCHuman Foods ProgramDietary Supplement/Adulterated
Jun 25, 2025Thang Botanicals, Inc. D/B/A 7ΩHMZ, 7-OHMZ, Or 7OHMZHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Jun 25, 2025Xtreme Tools International, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 23, 2025A.D. Berries @ More LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jun 18, 2025Dynamic Blending Specialists, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 18, 2025Lystn LLC Dba Answers Pet FoodCenter for Veterinary MedicineCGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jun 18, 2025Peter Michael, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
Jun 16, 2025IndulgeRx Brands, IncHuman Foods ProgramNew Drug/Misbranded
Jun 16, 2025Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. SirketiCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 13, 2025InVia Fertility Specialists, PLLCCenter for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jun 13, 2025Visgeneer, IncCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/Misbranded
Jun 13, 2025Www.Soma4Ever.ComCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Jun 12, 2025Healwell Homeo Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 12, 2025J.D. Heiskell Holdings LLCCenter for Veterinary MedicineCGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jun 12, 2025Kenil Healthcare Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 12, 2025Www.Buynetmeds.ComCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Jun 11, 2025Jalisco Fresh Produce, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jun 10, 2025Www.Buyprosoma.ComCenter for Drug Evaluation and Research (CDER)Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Jun 9, 2025Boothwyn Pharmacy LLCCenter for Veterinary MedicineUnapproved New Animal Drug/Adulterated/Misbranded
Jun 9, 2025Reset Technology CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jun 6, 2025Horizon Tool Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jun 6, 2025Xin Ao International Group Corp.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jun 6, 2025Zhejiang Huahai Pharmaceutical Co., Ltd.Office of Manufacturing QualityCGMP/Finished Pharmaceuticals/Adulterated
Jun 5, 2025Sterling DistributorsCenter for Drug Evaluation and Research (CDER)Drug Supply Chain Security Act (DSCSA) Violations
Jun 4, 2025Www.Bigpharmausa.ComCenter for Drug Evaluation and Research (CDER)Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Jun 3, 2025Insightra Medical Inc.Center for Devices and Radiological HealthMedical Device Reporting/Misbranded
Jun 3, 2025Zest US Wholesale Inc.Division of West Coast ImportsForeign 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
Jun 30, 2025Unipack LLCDrugsUnited States
Jun 27, 2025BSO, LLCDrugsUnited States
Jun 27, 2025DAWTONA Sp.Zo.OFood/CosmeticsPoland
Jun 27, 2025Elite Vapor, LLCTobaccoUnited States
Jun 27, 2025Sri Krishna Pharmaceuticals LimitedDrugsIndia
Jun 27, 2025Zip Foods Importers, IncFood/CosmeticsUnited States
Jun 26, 2025Atlantis Laboratories, Inc.DrugsUnited States
Jun 26, 2025GT Hyper DistibutionTobaccoUnited States
Jun 26, 2025Purcell InternationalFood/CosmeticsUnited States
Jun 25, 2025AK Wholesale, Inc.TobaccoUnited States
Jun 25, 2025Sichuan Shifang Danshi Food Co., LtdFood/CosmeticsChina
Jun 24, 2025Chemisphere CorporationDrugsUnited States
Jun 24, 2025MIN JIANG FOOD STORE INCFood/CosmeticsUnited States
Jun 23, 2025Private Label Skin CareDrugsUnited States
Jun 20, 2025Analytical Food Laboratories Inc.DrugsUnited States
Jun 20, 2025Weifang Green Life Foods Co.,LtdFood/CosmeticsChina
Jun 19, 2025Foremount Enterprise Co., Ltd.DevicesTaiwan
Jun 19, 2025King FarmVeterinaryUnited States
Jun 18, 2025BC VAPINGAPETobaccoUnited States
Jun 18, 2025Physitemp Instruments, LLCDevicesUnited States
Jun 18, 2025Seaway Pharma Inc.DrugsUnited States
Jun 18, 2025Xttrium Laboratories, Inc.DrugsUnited States
Jun 16, 2025Candymar Produce IncFood/CosmeticsUnited States
Jun 16, 2025Jay Parker & Sons, LLCVeterinaryUnited States
Jun 13, 20253D Imaging Drug Design And Development LLCDrugsUnited States
Jun 13, 2025ALK-Abello, Inc.DrugsUnited States
Jun 13, 2025Blendco LLCVeterinaryUnited States
Jun 13, 2025Conceive Fertility CenterBiologicsUnited States
Jun 13, 2025EPM Packaging, Inc.DrugsUnited States
Jun 13, 2025LBC Products, Inc.TobaccoUnited States
Jun 13, 2025Sun Pharmaceutical Industries Ltd.DrugsIndia
Jun 12, 2025Absolute Vapor LLCTobaccoUnited States
Jun 12, 2025Cavevi Naturals LLCFood/CosmeticsUnited States
Jun 12, 2025Contec Medical Systems Co., Ltd.DevicesChina
Jun 12, 2025HS Global Distribution, LLCTobaccoUnited States
Jun 12, 2025JAS Diagnostics, Inc./Drew Scientific, Inc.DevicesUnited States
Jun 12, 2025QuestSpecialty CorporationDrugsUnited States
Jun 12, 2025White River DairyVeterinaryUnited States
Jun 11, 2025GOLDEN EAGLE DISTRIBUTORSTobaccoUnited States
Jun 11, 2025NYUMBANI HAKUNA MATATA LLCFood/CosmeticsUnited States
Jun 11, 2025RSV Pita, Inc.Food/CosmeticsUnited States
Jun 10, 2025MedisourceRxDrugsUnited States
Jun 10, 2025REAL CONSERVERA ESPANOLA, S.L.Food/CosmeticsSpain
Jun 10, 2025Seafood Brothers Inc.Food/CosmeticsUnited States
Jun 9, 2025Boothwyn Pharmacy LLCDrugsUnited States
Jun 6, 2025DaColonia Alimentos Naturais LtdaFood/CosmeticsBrazil
Jun 6, 2025Greenfruit Avocados, LLCFood/CosmeticsUnited States
Jun 6, 2025Knickerbocker 365 Inc.Food/CosmeticsUnited States
Jun 6, 2025Medi-Fare DrugDrugsUnited States
Jun 6, 2025Preservation Solutions, Inc.DevicesUnited States
Jun 5, 2025Gemperle Bros.Food/CosmeticsUnited States
Jun 5, 2025LA EJuice, LLCTobaccoUnited States
Jun 5, 2025Newalta Dairy LLCVeterinaryUnited States
Jun 5, 2025RHYZ ANALYTICAL LABSDrugsUnited States
Jun 4, 2025DeVere Company, Inc.DrugsUnited States
Jun 4, 2025Exthera Medical CorporationDevicesUnited States
Jun 4, 2025Pan-African Food Distributors Inc.Food/CosmeticsUnited States
Jun 2, 2025American Contract Systems IncDevicesUnited States

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP34
21 CFR 117.35(a)Sanitary operations - Plant sanitation30
21 CFR 820.100(a)Lack of or inadequate procedures24
21 CFR 211.22(d)Procedures not in writing, fully followed23
21 CFR 117.35(c)Pest control20
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls20
21 CFR 117.10Personnel19
21 CFR 211.192Written record of investigation incomplete19
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard18
21 CFR 111.70(e)Specifications - finished dietary supplement17

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
Jun 30, 2025Philips Respironics, Inc.DevicesDevices may possess a programming error resulting in an incorrect device configuration.
Jun 30, 2025Philips Respironics, Inc.DevicesDevices may possess a programming error resulting in an incorrect device configuration.
Jun 30, 2025Philips Respironics, Inc.DevicesDevices may possess a programming error resulting in an incorrect device configuration.
Jun 29, 2025Wiet Peeters Farm Products LimitedFoodPotential to be contaminated with Listeria monocytogenes
Jun 29, 2025Wiet Peeters Farm Products LimitedFoodPotential to be contaminated with Listeria monocytogenes
Jun 29, 2025Wiet Peeters Farm Products LimitedFoodPotential to be contaminated with Listeria monocytogenes
Jun 28, 2025CHETAK NEW YORK LLCFoodProduct tested positive Salmonella .
Jun 28, 2025CHETAK NEW YORK LLCFoodProduct tested positive Salmonella .
Jun 27, 2025Sandoz IncDrugsLabeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for…
Jun 27, 2025Sandoz IncDrugsLabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection…
Jun 26, 2025Hamilton Medical AGDevicesVentilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will…
Jun 25, 2025Shang Hao Jia, IncFoodProduct does not declare allergen ingredient sesame.
Jun 23, 2025Abiomed, Inc.DevicesA potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Jun 23, 2025Thoratec LLCDevicesDue to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the…
Jun 23, 2025Thoratec LLCDevicesDue to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the…
Jun 20, 2025Baxter Healthcare CorporationDevicesCertain Spectrum infusion pumps may have an incorrect version of software.
Jun 20, 2025Baxter Healthcare CorporationDevicesCertain Spectrum infusion pumps may have an incorrect version of software.
Jun 19, 2025Face Rock Creamery LLCFoodPotential to be contaminated with Listeria monocytogenes
Jun 18, 2025Krasnyi Oktyabr USA IncFoodClostridium botulinum (uneviscerated fish)
Jun 18, 2025Lipari Foods Operating Company, LLC.FoodUndeclared milk
Jun 17, 2025Intersurgical IncDevicesPotential for faulty devices as a result of depleted batteries.
Jun 17, 2025SABORES FIT BAKERYFoodUndeclared allergens: Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts) on label and…
Jun 17, 2025SABORES FIT BAKERYFoodUndeclared allergens: Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts) on label and…
Jun 17, 2025SABORES FIT BAKERYFoodUndeclared allergens: Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts) on label and…
Jun 17, 2025SABORES FIT BAKERYFoodUndeclared allergens: Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts) on label and…
Jun 17, 2025SABORES FIT BAKERYFoodUndeclared allergens: Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts) on label and…
Jun 16, 2025Draeger, Inc.DevicesReports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Jun 16, 2025Draeger, Inc.DevicesReports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Jun 16, 2025Draeger, Inc.DevicesReports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Jun 16, 2025Draeger, Inc.DevicesReports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Jun 16, 2025LLK TRADING INCFoodProduct tested positive for L. monocytogenes .
Jun 16, 2025Weaver Nut Company, IncFoodundeclared milk allergen
Jun 16, 2025Weaver Nut Company, IncFoodUndeclared Milk Allergen
Jun 16, 2025Weaver Nut Company, IncFoodUndeclared Milk Allergen
Jun 16, 2025Weaver Nut Company, IncFoodundeclared milk allergen
Jun 13, 2025FUENTES FARMS LLCFoodCucumbers have the potential to be contaminated with Salmonella
Jun 11, 2025Vita Warehouse Corp.FoodContains undeclared peanut
Jun 10, 2025HOFOOD99 INC.FoodProduct may be contaminated with Listeria monocytogenes.
Jun 10, 2025Mightylicious Inc.FoodUndeclared Milk
Jun 9, 2025Alma Pak International LLCFoodListeria monocytogenes. During routine testing the firm received positive test results of Listeria monocytogenes on their finished product.
Jun 9, 2025Seal The Seasons, IncFoodListeria monocytogenes. The firm was notified by their supplier that the product is contaminated with Listeria monocytogenes.
Jun 6, 2025August Egg CompanyFoodPotential contamination with Salmonella.
Jun 6, 2025Church & Dwight IncDrugsMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Jun 6, 2025Church & Dwight IncDrugsMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Jun 6, 2025Church & Dwight IncDrugsMicrobial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Jun 6, 2025P East Trading CorpFoodClostridium botulinum (uneviscerated fish)
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 5, 2025Hy-VeeFoodPotential contamination with Listeria monocytogenes
Jun 4, 2025Bornstein Seafoods IncFoodThe recall was the result of the firm's routine sampling program and Listeria monocytogenes was detected in an in-process shrimp sample in…
Jun 3, 2025Given Imaging Ltd.DevicesIt has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the…
Jun 3, 2025Hamilton Medical AGDevicesA mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to…
Jun 2, 2025Amneal Pharmaceuticals, LLCDrugsMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

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.