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FDA Warning Letters, 483s and Recalls: October 2025

FDA enforcement records dated October 2025: 26 warning letters outside tobacco (plus 30 tobacco letters), 43 OAI inspections and 80 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
Oct 31, 2025Apotex Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 30, 2025Owen Biosciences, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 29, 2025World Perfumes Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 28, 2025Hong Qiangxing Shenzhen Electronics LimitedCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Oct 27, 2025DermaRite Industries, LLCCenter for Drug Evaluation and Research (CDER)Nonprescription/OTC
Oct 27, 2025IBSPOT.Com Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 24, 2025Ocho Rios Atlanta Inc.Division of Southeast ImportsForeign Supplier Verification Program (FSVP)
Oct 23, 2025MG GROUP USAOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
Oct 21, 2025Robert G. Miller Dba Granja AsomanteHuman Foods ProgramPHS Act/Shell Egg Regulation/Adulterated
Oct 21, 2025Uriel Pharmacy, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 17, 2025Liebel-Flarsheim Company LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 16, 2025The Tranzonic Companies/Innocore Sales & Marketing Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 15, 2025East Bay Wholesale CorporationDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Oct 15, 2025Onlineotcmeds.ComCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 10, 2025Acme United CorporationCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 10, 2025Foshan Yiying Hygiene Products Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 10, 2025PQ Pharmacy, LLCCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Oct 10, 2025RNA Bio/Pharma, IncorporatedCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 10, 2025Scientific Protein Laboratories, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Oct 9, 2025Melcare Biomedical Pty LtdCenter for Drug Evaluation and Research (CDER)Nonprescription/OTC.”
Oct 9, 2025Taizhou Kangping Medical Science And Technology Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Oct 9, 2025Turkana Food Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
Oct 9, 2025V & L Produce, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 6, 2025Www.Usmedschoice.ComCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
Oct 3, 2025Qianjiang Kingphar Medical Material Co Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/Misbranded
Oct 2, 2025Contec Medical Systems Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/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
Oct 31, 2025Active Cosmetics Manufacturing IncDrugsUnited States
Oct 31, 2025Batra EnterprisesFood/CosmeticsIndia
Oct 31, 2025BioMed Laboratories, LLC.DrugsUnited States
Oct 30, 2025Crevel Distribution Inc.Food/CosmeticsUnited States
Oct 30, 2025Longhorn Vaccines And Diagnostics LLCDevicesUnited States
Oct 30, 2025SCA Pharmaceuticals, Inc.DrugsUnited States
Oct 29, 2025Brunkow Cheese Of Wisconsin, Inc.Food/CosmeticsUnited States
Oct 29, 2025Carver's OrchardFood/CosmeticsUnited States
Oct 29, 2025ClavmedDevicesPoland
Oct 29, 2025Flax & More CorporationFood/CosmeticsUnited States
Oct 28, 2025Banchandanji Co. Ltd.Food/CosmeticsKorea (the Republic of)
Oct 28, 2025Criticare Technologies, Inc.DevicesUnited States
Oct 27, 2025Fuji Shokuhin Co., Ltd.Food/CosmeticsJapan
Oct 24, 2025CareFusion 213, LLCDrugsUnited States
Oct 24, 2025Foshan Miwei Cosmetics Co., Ltd.DrugsChina
Oct 24, 2025Yangzhou H&R Plastic Daily Chemical Co., Ltd.DrugsChina
Oct 23, 2025Asli Foods, IncFood/CosmeticsUnited States
Oct 23, 2025EO Products, LLCDrugsUnited States
Oct 23, 2025Italfoods, Inc.Food/CosmeticsUnited States
Oct 23, 2025Sheffield Precision Medical LimitedDevicesUnited Kingdom
Oct 23, 2025SV Labs CorporationDrugsUnited States
Oct 22, 2025LightwaveDevicesUnited States
Oct 22, 2025Lucky Premium Treats LlcVeterinaryUnited States
Oct 21, 2025Ava IncDrugsUnited States
Oct 21, 2025Beyond Laser Systems, LLCDevicesUnited States
Oct 20, 2025Par Health USA, LLCVeterinaryUnited States
Oct 20, 2025Stalk Tech Corp.DevicesUnited States
Oct 17, 2025IsoTis OrthoBiologics, Inc.DevicesUnited States
Oct 17, 2025Neutripure CorporationDrugsUnited States
Oct 17, 2025Wisemen Wholesale, Inc.TobaccoUnited States
Oct 16, 2025Nature's Elements, Inc.Food/CosmeticsUnited States
Oct 15, 2025Apozeal Pharmaceuticals Inc.DrugsUnited States
Oct 15, 2025Nutratech LLCFood/CosmeticsUnited States
Oct 15, 2025YASMINA IMPORTS SVC Inc.Food/CosmeticsUnited States
Oct 14, 2025Imu-Tek Animal Health, IncorporatedFood/CosmeticsUnited States
Oct 14, 2025Medline Industries, LPDrugsUnited States
Oct 14, 2025Shineluck Foods, Inc.Food/CosmeticsUnited States
Oct 10, 2025Vascular Solutions, LLC (A Subsidiary Of Teleflex)DevicesUnited States
Oct 9, 2025Moonlight Packing CorporationFood/CosmeticsUnited States
Oct 9, 2025Tarry Medical Products, Inc.DrugsUnited States
Oct 7, 2025MexHass Inc.Food/CosmeticsUnited States
Oct 6, 2025Syfrett Feed Company, Inc.VeterinaryUnited States
Oct 2, 2025OraLabs LLCDrugsUnited 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 sanitation27
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement26
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard18
21 CFR 820.198(a)Lack of or inadequate complaint procedures18
21 CFR 117.10Personnel15
21 CFR 123.11(b)Sanitation monitoring documentation15
21 CFR 211.22(d)Procedures not in writing, fully followed15
21 CFR 820.100(a)Lack of or inadequate procedures15
21 CFR 117.35(c)Pest control14
21 CFR 123.6(b)No HACCP plan14

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
Oct 31, 2025BULK & ORGANIC LLCFoodPossible Salmonella Richmond
Oct 30, 2025Lotus Vaping Technologies, LLCFoodProduct has the potential to be contaminated with Salmonella
Oct 30, 2025Lotus Vaping Technologies, LLCFoodProduct has the potential to be contaminated with Salmonella
Oct 30, 2025Lotus Vaping Technologies, LLCFoodProduct has the potential to be contaminated with Salmonella
Oct 30, 2025Lotus Vaping Technologies, LLCFoodProduct has the potential to be contaminated with Salmonella
Oct 30, 2025Olympus Corporation Of The AmericasDevicesPotential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed…
Oct 29, 2025GBC Food Services, LLCFoodPeaches provided by Moonlight Peaches potentially contaminated with Listeria.
Oct 29, 2025JFE FRANCHISING INCFoodPeaches provided by Moonlight Peaches potentially contaminated with Listeria.
Oct 29, 2025Otsuka ICU Medical LLCDrugsLabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq…
Oct 29, 2025Otsuka ICU Medical LLCDrugsLabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq…
Oct 29, 2025Plenus Group Inc.FoodProducts contain undeclared shrimp (crustacean shellfish)
Oct 29, 2025Siluetaya, LLCFoodProduct contains yellow oleander
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025Moonlight Packing CorporationFoodPotential contamination with Listeria monocytogenes.
Oct 28, 2025New Hoque And Sons, Inc.FoodUn-eviscerated fish may be contaminated with Clostridia botulinum.
Oct 27, 2025MAMTAKIM, Inc.FoodClostridium botulinum (uneviscerated fish)
Oct 27, 2025MAMTAKIM, Inc.FoodClostridium botulinum (uneviscerated fish)
Oct 27, 2025Pacific International MarketingFoodPotential contamination with Salmonella.
Oct 27, 2025Pacific International MarketingFoodPotential contamination with Salmonella.
Oct 27, 2025Pacific International MarketingFoodPotential contamination with Salmonella.
Oct 27, 2025Pacific International MarketingFoodPotential contamination with Salmonella.
Oct 27, 2025WFM Purchasing, LPFoodTwin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole…
Oct 27, 2025WFM Purchasing, LPFoodTwin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole…
Oct 25, 2025Peterson Company IncFoodItem #29608 Farmhouse White is recalled due to E. coli O103:H2.
Oct 25, 2025Peterson Company IncFoodItem #28855 Whatcom Blue is recalled due to E. coli O103:H2
Oct 24, 2025MeriCal, LLCFoodPotential contamination of Salmonella Richmond
Oct 24, 2025Twin Sisters Creamery, LLCFoodRaw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.
Oct 24, 2025Twin Sisters Creamery, LLCFoodRaw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.
Oct 24, 2025Twin Sisters Creamery, LLCFoodRaw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.
Oct 24, 2025Twin Sisters Creamery, LLCFoodRaw milk Peppercorn cheese is recalled due to E.coli O26:H11
Oct 23, 2025Echo Lake Foods, Inc.FoodPotential Listeria monocytogenes contamination.
Oct 20, 2025ANTHONY TRINH, 123Herbals LLCDrugsMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Oct 20, 2025Jacob KingFoodProduct may be contaminated with Salmonella
Oct 17, 2025CareFusion 303, Inc.DevicesIf infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion…
Oct 16, 2025M.C.I. Foods, Inc.FoodCooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Oct 16, 2025M.C.I. Foods, Inc.FoodCooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Oct 15, 2025Made Fresh Salads IncFoodProducts may be contaminated with Listeria monocytogenes.
Oct 15, 2025Made Fresh Salads IncFoodProducts may be contaminated with Listeria monocytogenes.
Oct 14, 2025Publix Super Markets, Inc.FoodUndeclared Eggs
Oct 13, 2025TMJ Solutions IncDevicesPatient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Medline Industries, LPDevicesFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may…
Oct 10, 2025Teasdale Foods, Inc.FoodUndeclared allergen - milk
Oct 10, 2025Teasdale Foods, Inc.FoodUndeclared allergen - milk
Oct 9, 2025Glycar SA Pty., Ltd.DevicesThe impacted lot may not meet the required tensile strength specification.
Oct 9, 2025Glycar SA Pty., Ltd.DevicesThe impacted lot may not meet the required tensile strength specification.
Oct 8, 2025Mohamed HagarDrugsMarketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Oct 8, 2025Sprouts Farmers MarketFoodProduct may contain Listeria monocytogenes.
Oct 8, 2025Tai Foong USA IncFoodUndeclared shrimp
Oct 7, 2025Kenz Henz LLCFoodEggs may be contaminated with Salmonella.
Oct 6, 2025Tandem Diabetes Care, Inc.DevicesInsulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false…
Oct 3, 2025New York Mutual Trading, Inc.FoodUndeclared allergen ingredients (fish, soy, and wheat)
Oct 3, 2025Twin Marquis, LLCFoodProduct contains undeclared egg, FD&C Yellow 5, and FD&C Yellow 6.
Oct 2, 2025Cerenovus IncDevicesDetachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for…
Oct 2, 2025Giant Eagle, Inc.FoodRecall notification from supplier of Potential listeria contamination.
Oct 2, 2025Giant Eagle, Inc.FoodRecall notification from supplier of Potential listeria contamination.
Oct 2, 2025Giant Eagle, Inc.FoodRecall notification from supplier of Potential listeria contamination.
Oct 2, 2025ICU Medical, Inc.DevicesIV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may…
Oct 1, 2025Abiomed, Inc.DevicesPotential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Oct 1, 2025DEMERS FOOD GROUP LLCFoodContains Linguine manufactured by Nate's Fine Foods LLC recalled for Listeria monocytogenes and implicated in ongoing outbreak
Oct 1, 2025Doan's Dessert And CoffeeFoodUndeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Oct 1, 2025Doan's Dessert And CoffeeFoodUndeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Oct 1, 2025Siemens Medical Solutions USA, IncDevicesThere is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet…

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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.