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FDA Warning Letters, 483s and Recalls: July 2026

FDA enforcement records dated July 2026: 36 warning letters outside tobacco (plus 5 tobacco letters), 14 OAI inspections and 55 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
Jul 31, 2026FairyGene, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Jul 31, 2026H2 BEV, LLC And H2 RENU, INCHuman Foods ProgramAcidified Foods/Emergency Permit Control/Adulterated/Misbranded
Jul 30, 2026DeJong Family Dairy, LLCCenter for Veterinary MedicineNew Animal Drug/Adulterated
Jul 30, 2026Lico Industries, LLC., D.B.A. American Towelette CompanyCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 29, 2026La Cabana Food Distributing, Inc.Human Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Jul 27, 2026Maria E. De La Torre Silva, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
Jul 27, 2026Vargas Produce LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 27, 2026Woodbine Products Company Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 24, 2026Dabur India LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 24, 2026Nipro Renal Solutions USA, CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jul 24, 2026Thomas Brunner Hygiene GmbHCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Jul 24, 2026Wilson LivestockCenter for Veterinary MedicineNew Animal Drug/Adulterated
Jul 23, 2026ABS CorporationCenter for Veterinary MedicineCGMP/Finished Pharmaceuticals/Adulterated
Jul 23, 2026Eherbs Imports, IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 22, 2026Ohom Padmaavathii, LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 22, 2026Ruukoo International Food Market Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 21, 2026Koven Technologies, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jul 20, 2026Fil-Bay Import, Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 16, 2026Island Kinetics, Inc. D.B.A. CoValence LaboratoriesCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Jul 16, 2026San Jorge Produce LLCHuman Foods ProgramForeign Supplier Verification Program (FSVP)
Jul 15, 2026AAL Trading Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 15, 2026LDNN Produce Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 14, 2026Friend’S Stable And Orchard, Inc.Human Foods ProgramFood/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jul 13, 2026Almon Healthcare Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jul 13, 2026BioMylz Pvt. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Jul 13, 2026Shimoga ChemicalsCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jul 10, 2026Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.Center for Drug Evaluation and Research (CDER)In Vivo Bioavailability-Bioequivalence Studies – Clinical
Jul 9, 2026VasoCorp, Inc.Human Foods ProgramUnapproved New Drugs/Misbranded
Jul 8, 2026Beauty Store LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 8, 2026IJAJ Group Inc DBA Sanz Wholesale FoodsOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Jul 8, 2026Spa De Soleil, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 7, 2026Specialty Health Products CO, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jul 6, 2026Waves And Wine, Inc.Center for Veterinary MedicineCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Jul 2, 2026Good Stuff CacaoHuman Foods ProgramNew Drug/Misbranded
Jul 2, 2026International Medication Systems LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 2, 2026Piquin Y Sabores Distributors 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
Jul 24, 2026Sterling Pharmaceutical Services LLCDrugsUnited States
Jul 23, 2026BIOPSYBELL S.R.L.DevicesItaly
Jul 23, 2026Distribuidora Jazmin LLCFood/CosmeticsUnited States
Jul 23, 2026Fuller Industries IncDrugsUnited States
Jul 23, 2026Importaciones La Bufa LLCFood/CosmeticsUnited States
Jul 22, 2026Medline Industries, LPDrugsUnited States
Jul 21, 2026Endovascular Engineering, IncDevicesUnited States
Jul 17, 2026EuroAPI Italy SRLDrugsItaly
Jul 17, 2026I. Shay Cosmetics IncDrugsUnited States
Jul 15, 2026ART MX, LLCFood/CosmeticsUnited States
Jul 15, 2026Liaoning Taihong Biotechnology Co., Ltd.Food/CosmeticsChina
Jul 14, 2026Aspen SA Sterile Operations (Pty) Ltd.DrugsSouth Africa
Jul 13, 2026Conopco Inc. D/B/A UnileverDrugsUnited States
Jul 10, 2026Playtex Manufacturing IncDrugsUnited 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 sanitation33
21 CFR 1.502(a)Develop FSVP28
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard23
21 CFR 117.35(c)Pest control21
21 CFR 123.6(b)No HACCP plan20
21 CFR 111.70(b)Specifications - components18
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement18
21 CFR 111.70(e)Specifications - finished dietary supplement15
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls15
ISO 13485:2016 Clause 8.2.2Correction or corrective action resulting from complaint handling not documented15

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
Jul 31, 2026Liebel-Flarsheim Company LLCDrugsPresence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Jul 30, 2026Bard Access Systems, Inc.DevicesAfter placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or…
Jul 29, 2026Kerry, IncFoodUndeclared allergen (egg)
Jul 29, 2026Nova Biomedical CorporationDevicesA software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to…
Jul 29, 2026Nova Biomedical CorporationDevicesA software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to…
Jul 29, 2026Nova Biomedical CorporationDevicesA software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to…
Jul 29, 2026Nova Biomedical CorporationDevicesA software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to…
Jul 29, 2026Nova Biomedical CorporationDevicesA software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to…
Jul 28, 2026529 COMMERCE, LLCFoodUndeclared Egg
Jul 24, 2026American Regent, Inc.DrugsPresence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Jul 24, 2026Baxter Healthcare CorporationDrugsPresence of Particulate Matter
Jul 23, 2026Medical Action Industries, Inc. 306DevicesKits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Jul 23, 2026Medical Action Industries, Inc. 306DevicesKits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Jul 22, 2026AVID Medical, Inc.DevicesConvenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
Jul 22, 2026Coast Citrus DistributorsFoodPotential Salmonella Javiana contamination
Jul 22, 2026MIDWEST POULTRY SERVC C/O H & LELECTRICFoodPossible Salmonella Enteritidis
Jul 22, 2026MIDWEST POULTRY SERVC C/O H & LELECTRICFoodPossible Salmonella Enteritidis
Jul 20, 2026Piazza Produce (Dba CIBUS Fresh)FoodPossible Cyclospora Contamination
Jul 19, 2026FACTORY6, INC.FoodPossible Salmonella in Moringa Leaf Powder product.
Jul 18, 2026M.G. Foods, Inc.FoodUndeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is…
Jul 17, 2026Botticelli Foods, LLCFoodProduct may be contaminated with Salmonella.
Jul 17, 2026Sunny Pharmtech Inc.DrugsPresence of Particulate Matter; identified as stainless steel
Jul 17, 2026Sunny Pharmtech Inc.DrugsPresence of Particulate Matter; identified as stainless steel
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 17, 2026Taylor Farms De Mexico S. De R.L. De C.V.FoodPotential Cyclospora contamination.
Jul 15, 2026BMC Medical Co., Ltd.DevicesRetroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Jul 14, 2026AVID Medical, Inc.DevicesConvenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus…
Jul 13, 2026KHONG GUAN (HQ)FoodUndeclared peanuts.
Jul 13, 2026KHONG GUAN (HQ)FoodUndeclared peanuts.
Jul 9, 2026Boston Scientific CorporationDevicesPotential for arterial sheath tip separation or partial tip separation during use.
Jul 9, 2026Boston Scientific CorporationDevicesPotential for arterial sheath tip separation or partial tip separation during use.
Jul 8, 2026Green Jeeva LLCFoodMoringa Powder ingredient positive for salmonella
Jul 6, 2026Fayus Inc.FoodUndeclared milk.
Jul 6, 2026Spectra Medical Devices, LlcDevicesManufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised…
Jul 3, 2026Frutas Y Hortalizas Del Sur S.A.FoodPotential E. coli O145:H28 Contamination
Jul 1, 2026Victory Medical Center PharmacyDrugsMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

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.