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FDA Warning Letters, 483s and Recalls: August 2026

FDA enforcement records dated August 2026: 41 warning letters outside tobacco (plus 2 tobacco letters), 7 OAI inspections and 104 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
Aug 28, 2026Tipical Latin Food, Corp. DBA La PraderaHuman Foods ProgramCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Aug 27, 2026Andrighetto Produce Inc Dba Shasta Produce IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 27, 2026Jabil Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 27, 2026Stephen J. Fallon, Ph.D.Center for Biologics Evaluation and Research (CBER)Bioresearch Monitoring Program/Institutional Review Board (IRB)
Aug 27, 2026Union Trade Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 26, 2026Peter Schiff EnterprisesCenter for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Aug 25, 2026Advance-Esthetic LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Aug 25, 2026Fresenius Medical Care AG & Co. KGaACenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 24, 2026BioDrive, Inc.Human Foods ProgramDietary Supplement/Adulterated
Aug 24, 2026NuScience Peptides LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Aug 24, 2026Peak Performance PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Aug 24, 2026Peptide Partners LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Aug 24, 2026Royal Peptides LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Aug 24, 2026TXP Innovations LLC Dba Tex PeptidesCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Aug 21, 2026Lion Street Medical, D/B/A Pensar Medical LLCCenter for Devices and Radiological HealthMedical Device Reporting/Misbranded
Aug 21, 2026Raaw Energy LLCCenter for Veterinary MedicineAdulterated Animal Foods/Misbranded
Aug 20, 2026South Asian Food Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Aug 19, 2026Next Medical Products Company, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Aug 18, 2026Binh Minh TofuHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Aug 18, 2026B&P Mutual CorpOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 18, 2026PReye, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Aug 18, 2026Reliance Life Sciences Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 18, 2026Shoolin Pharma Chem LLPCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Aug 17, 2026Importaciones La Bufa LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 14, 2026R3 Medical CompaniesCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Unlicensed Biological Product Violations
Aug 13, 2026Bo Wah Enterprises IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 13, 2026Distribuidora Jazmin LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 13, 2026Eugia Pharma Specialities LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 13, 2026Suretec Innovations, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated and Misbranded
Aug 12, 2026Amgen Inc.The Office of Prescription Drug Promotion (OPDP)Drug Product/Misbranded, False & Misleading Claims
Aug 12, 2026Auriga Research Pvt. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 12, 2026K.C. Pharmaceuticals, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 7, 2026Pine Pharmaceuticals, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Aug 7, 2026Safrel Pharmaceuticals LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Aug 6, 2026Tianjin Kilo Pharmaceutical Sci-Tech Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Aug 5, 2026Lewis Sausage Company Inc.Center for Veterinary MedicineCGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Aug 5, 2026Quantum Star LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 5, 2026Viva Raw LLCCenter for Veterinary MedicineAdulterated Animal Foods/Misbranded
Aug 4, 2026American Pharma Mfg. Inc.Human Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Aug 4, 2026Mesquite Gourmet LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Aug 4, 2026Stokes Healthcare Inc. Dba Epicur PharmaCenter for Veterinary MedicineAnimal Drugs/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
Aug 21, 2026DATIL FRESH PRODUCE LLCFood/CosmeticsUnited States
Aug 19, 2026Pharmalogic New York City, LLCDrugsUnited States
Aug 13, 2026Raw Bistro, Inc.VeterinaryUnited States
Aug 12, 2026Mountainside Medical Equipment, Inc.DrugsUnited States
Aug 12, 2026Steril-Gene Life Sciences Private LtdDrugsIndia
Aug 6, 2026Star Ocean Wholesale Foods, Inc.Food/CosmeticsUnited States
Aug 5, 2026Luce Enterprises LLCFood/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 sanitation30
21 CFR 111.70(b)Specifications - components21
21 CFR 111.70(e)Specifications - finished dietary supplement21
21 CFR 1.502(a)Develop FSVP21
21 CFR 111.210Master manufacturing record - record requirements17
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement17
21 CFR 117.10Personnel15
21 CFR 111.260Batch record - required information14
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard14
21 CFR 117.35(c)Pest control14

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
Aug 28, 2026Frutas Y Hortalizas Del Sur S.A.FoodPotential E. coli O145:H28 Contamination
Aug 26, 2026FOODS ALIVE INC.FoodPotential Salmonella contamination
Aug 25, 2026Optimus Inc. D/B/A/ Markys CaviarFoodThe firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes.
Aug 24, 2026Boston Scientific CorporationDevicesTip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact…
Aug 24, 2026El Ruisenor De Mexico, Inc.Foodundeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2)
Aug 24, 2026El Ruisenor De Mexico, Inc.Foodundeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Sulfites)
Aug 24, 2026El Ruisenor De Mexico, Inc.Foodundeclared allergen ingredient (Milk)
Aug 24, 2026El Ruisenor De Mexico, Inc.Foodundeclared allergen ingredient (Milk, Wheat, Sesame, Soy)
Aug 24, 2026El Ruisenor De Mexico, Inc.Foodundeclared allergen ingredient (Wheat)
Aug 23, 2026International Sprout Holdings, IncFoodPotential E. coli and Salmonella contamination
Aug 22, 2026Everything Sprouts, LLCFoodSprouts may be contaminated with STEC E. coli and/or Salmonella.
Aug 22, 2026Everything Sprouts, LLCFoodSprouts may be contaminated with STEC E. coli and/or Salmonella.
Aug 22, 2026Everything Sprouts, LLCFoodSprouts may be contaminated with STEC E. coli and/or Salmonella.
Aug 22, 2026Everything Sprouts, LLCFoodSprouts may be contaminated with STEC E. coli and/or Salmonella.
Aug 21, 2026VITRUVIAS THERAPEUTICS INCDrugsSuperpotent Drug
Aug 19, 2026B BRAUN MEDICAL INCDrugsPresence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Aug 19, 2026BD SWITZERLAND SARLDevicesDue to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Aug 17, 2026Baxter Healthcare CorporationDrugsPresence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Aug 17, 2026Baxter Healthcare CorporationDrugsPresence of particulate matter: Particulates identified as fiberglass
Aug 17, 2026The Better Bakehouse Snack CompanyFoodUndeclared Milk.
Aug 14, 2026Medline Industries, LPDevicesPotential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may…
Aug 14, 2026Medline Industries, LPDevicesPotential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may…
Aug 14, 2026THE HAMPTON GROCERFoodProduct may be contaminated with Salmonella.
Aug 12, 2026Abiomed, Inc.DevicesThe potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Aug 12, 2026Abiomed, Inc.DevicesThe potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Aug 12, 2026Abiomed, Inc.DevicesThe potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Aug 12, 2026B BRAUN MEDICAL INCDrugsPresence of Particulate matter.
Aug 11, 2026American Regent, Inc.DrugsPresence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic…
Aug 11, 2026CooperSurgical, Inc.DevicesPotential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may…
Aug 11, 2026CooperSurgical, Inc.DevicesPotential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 11, 2026Medline Industries, LPDevicesThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental…
Aug 10, 2026AVID Medical, Inc.DevicesPotential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Aug 10, 2026AVID Medical, Inc.DevicesPotential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Aug 10, 2026AVID Medical, Inc.DevicesPotential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Aug 10, 2026AVID Medical, Inc.DevicesPotential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Aug 10, 2026Bard Access Systems, Inc.Devicesthis is a downstream recall of class I recall RES 98777
Aug 10, 2026Bard Access Systems, Inc.Devicesthis is a downstream recall of class I recall RES 98777
Aug 10, 2026Fresenius Kabi USA, LLCDrugsPresence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Aug 10, 2026Lidl US TRADINGFoodSalmonella. The firm received a positive test result of Salmonella in the product.
Aug 7, 2026EXOTIQUE FOODS CANADAFoodUndeclared Wheat.
Aug 7, 2026Savor Seasonings LLCFoodProduct tested positive for undeclared milk allergen.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026Taylor Fresh Foods IncFoodPotential contamination with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 7, 2026WFM Purchasing, LPFoodSalsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 6, 2026Given Imaging Ltd.DevicesCapsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of…
Aug 6, 2026Ron's Home Style Foods, Inc.FoodProducts were manufactured with jalapenos that have the potential to be contaminated with Salmonella
Aug 6, 2026Ron's Home Style Foods, Inc.FoodProducts were manufactured with jalapenos that have the potential to be contaminated with Salmonella
Aug 6, 2026Salata Dressings, LLCFoodThis recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier
Aug 5, 2026Dairyland Produce, LLCFoodJalapenos may be contaminated with Salmonella.
Aug 5, 2026GET FRESH PRODUCEFoodPotential Salmonella contamination
Aug 5, 2026Jaime's Foods ATX, LLCFoodUndeclared Egg Allergen
Aug 5, 2026Marina Del Rey Foods Inc.FoodProduct tested positive for undeclared milk.
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026NatureBest Pre-Cut & Produce LLcFoodJalapenos have the potential to be contaminated with Salmonella
Aug 5, 2026OPTIMAL BALANCE PHARMACYDrugsMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Aug 5, 2026Sirna And Sons Produce, IncFoodPotential Salmonella Javiana contamination

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