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FDA Warning Letters, 483s and Recalls: April 2025

FDA enforcement records dated April 2025: 32 warning letters outside tobacco (plus 30 tobacco letters), 56 OAI inspections and 63 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
Apr 30, 2025American Behavioral Research Institute, LLCCenter for Drug Evaluation and Research (CDER)Clinical Investigator (Sponsor)
Apr 30, 2025Ningbo Riway Industrial Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Apr 30, 2025Rechon Life Science ABCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 28, 2025Nana Barseghian, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
Apr 25, 2025Sarfez Pharmaceuticals, Inc.The Office of Prescription Drug Promotion (OPDP)False & Misleading Claims/Misbranded
Apr 23, 2025OSRX, Inc.Center for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Apr 23, 2025Www.24Hreup.BizCenter for Drug Evaluation and Research (CDER)Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Apr 22, 2025M.O.M. Enterprises, LLCHuman Foods ProgramCGMP/Dietary Supplement/Adulterated/Misbranded
Apr 17, 2025Amazon.Com, Inc.Center for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded/OTC
Apr 17, 2025Anti L’AgeHuman Foods ProgramCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Apr 17, 2025TKO Distribution, LLCHuman Foods ProgramAdulterated Human Foods/Misbranded
Apr 16, 2025Mentha & Allied Products Private Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Apr 15, 2025Gluten Free Remedies LLCHuman Foods ProgramDietary Supplement/Misbranded
Apr 15, 2025Shantou S.E.Z. Baojie Industry Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 14, 2025Cosco International, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Apr 11, 2025Livestock Nutrition CenterCenter for Veterinary MedicineCGMP/Non-Medicated Feed/Adulterated
Apr 9, 2025BEO Pharma Inc. Dba BEO Pharmaceuticals Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 9, 2025Dyno Manufacturing, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 9, 2025Noah Medical CorporationCenter for Devices and Radiological HealthCGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Apr 8, 2025Tailstorm Health Inc. Dba Medivant HealthCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Apr 7, 2025Bailey’S Wellness, LLC Dba Bailey’S CBDCenter for Veterinary MedicineUnapproved New Animal Drug Products
Apr 7, 2025Holista LLC Dba HolistaPetCenter for Veterinary MedicineUnapproved New Animal Drug Products
Apr 7, 2025House Of Alchemy LLC Dba CBD Dog Health Hamet & Love LLC Dba MycoDogCenter for Veterinary MedicineUnapproved New Animal Drug Products
Apr 7, 2025La Milagrosa 1 LLCHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Apr 7, 2025PMS4PMS, LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 7, 2025Revolution Foods, PBCHuman Foods ProgramFood Labeling/Misbranded
Apr 4, 2025ICU MedicalCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Apr 4, 2025Wuxi Medical Instrument Factory Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 2, 2025Empower Clinic Services, LLC Dba Empower PharmaCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Apr 2, 2025Empower Clinic Services, LLC Dba Empower PharmacyCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
Apr 2, 2025Taizhou Jingshang Cosmetics Technology Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Apr 1, 2025NWL Netherlands Services B.V.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/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
Apr 30, 2025INDIAN GROCERIES AND SPICES INCFood/CosmeticsUnited States
Apr 30, 2025Lohxa LLCDrugsUnited States
Apr 29, 2025Siddha Flower Essences, LLC.DrugsUnited States
Apr 28, 2025CDL Services, Inc.DrugsUnited States
Apr 28, 2025Louisville Reproductive CenterBiologicsUnited States
Apr 28, 2025McGuff Pharmaceuticals, Inc.DrugsUnited States
Apr 28, 2025ZEST US WHOLESALE INC.Food/CosmeticsUnited States
Apr 25, 2025Cdymax (India) Pharma Private LimitedDrugsIndia
Apr 25, 2025Innocore Sales & Marketing Inc.DrugsCanada
Apr 25, 2025Nutrix International LLCDrugsUnited States
Apr 25, 2025RadnostixDrugsUnited States
Apr 25, 2025UNIREGEN Spol S.R.O.Food/CosmeticsCzech Republic
Apr 24, 2025Absolutely NaturalDrugsUnited States
Apr 24, 2025Paragon 28, Inc.DevicesUnited States
Apr 23, 2025Englewood Lab, IncDrugsUnited States
Apr 23, 2025Miach OrthopaedicsDevicesUnited States
Apr 23, 2025SUPERCAN BULLY STICKS LLCVeterinaryUnited States
Apr 23, 2025Troya Del Campo USA LLCFood/CosmeticsUnited States
Apr 18, 2025C. B. Fleet Company, Inc.DrugsUnited States
Apr 17, 2025Advanced Instrumentations, Inc.DevicesUnited States
Apr 17, 2025Maribeth's Bakery, Inc.Food/CosmeticsUnited States
Apr 16, 2025Ailex Pharmaceuticals LLCDrugsUnited States
Apr 16, 2025Akralos Animal Nutrition LLCVeterinaryUnited States
Apr 16, 2025Ehsan NMI Sadri MDDrugsUnited States
Apr 16, 2025The Richline Group IncDevicesUnited States
Apr 15, 2025Aaa International Seafood Corp.Food/CosmeticsUnited States
Apr 15, 2025Fresh & Ready Foods LLCFood/CosmeticsUnited States
Apr 15, 2025Wai Wong LLCFood/CosmeticsUnited States
Apr 15, 2025ZOLL Medical CorporationDevicesUnited States
Apr 14, 2025Allen H. HurstFood/CosmeticsUnited States
Apr 14, 2025CC Pollen CompanyFood/CosmeticsUnited States
Apr 14, 2025Columbia Cosmetics Manufacturing, Inc.DrugsUnited States
Apr 14, 2025Hearthy Foods, Inc.Food/CosmeticsUnited States
Apr 14, 2025RemedyRePack Inc.DrugsUnited States
Apr 14, 2025SUNLAND GROWERS, INC.Food/CosmeticsUnited States
Apr 11, 2025Blossom PharmaceuticalsDrugsIndia
Apr 11, 2025RNA Bio/Pharma IncDrugsUnited States
Apr 11, 2025YAYLA AGRO GIDA SANAYI VE TICARET ANONIM SIRKETI MERSIN SUBESIFood/CosmeticsTurkey
Apr 10, 2025Zhongshan Luzon Food Co., LtdFood/CosmeticsChina
Apr 9, 2025LEVO AGDevicesSwitzerland
Apr 8, 2025Cosmetic Manufacturers (Aust) Pty Ltd.DrugsAustralia
Apr 8, 2025DermaRite Industries, LLCDrugsUnited States
Apr 8, 2025Liebel-Flarsheim Company LLCDrugsUnited States
Apr 8, 2025Microvascular Tissue, IncBiologicsUnited States
Apr 4, 2025BLIS Technologies LimitedFood/CosmeticsNew Zealand
Apr 4, 2025CA BOTANA International, Inc.DrugsUnited States
Apr 4, 2025PQ Pharmacy LLCDrugsUnited States
Apr 4, 2025QuVa Pharma, Inc.DrugsUnited States
Apr 3, 2025Bedner Growers, Inc.Food/CosmeticsUnited States
Apr 3, 2025Cromer Food Services, IncFood/CosmeticsUnited States
Apr 3, 2025Deluca's Bakery Corp.Food/CosmeticsUnited States
Apr 3, 2025Kath Khemicals LLCDrugsUnited States
Apr 3, 2025ParadigmTobaccoUnited States
Apr 3, 2025Thrive Health And Wellness, LLCDrugsUnited States
Apr 2, 2025Epic Laboratories LLCDrugsUnited States
Apr 2, 2025Raritan Pharmaceuticals, Inc.DrugsUnited 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 FSVP55
21 CFR 820.100(a)Lack of or inadequate procedures32
21 CFR 211.192Written record of investigation incomplete27
21 CFR 820.198(a)Lack of or inadequate complaint procedures25
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement24
21 CFR 117.35(a)Sanitary operations - Plant sanitation22
21 CFR 117.10Personnel21
21 CFR 111.70(e)Specifications - finished dietary supplement20
21 CFR 211.22(d)Procedures not in writing, fully followed20
21 CFR 111.70(b)Specifications - components18

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
Apr 30, 2025Ray & Mascari,IncFoodPotential Contamination of Salmonella.
Apr 30, 2025Williams Farms Produce Sales Co., Inc.FoodProduct may contain Salmonella.
Apr 29, 2025Hanshaw & Capling Farms, LLCFoodPotential Salmonella Contamination
Apr 29, 2025Turkana Food Inc.FoodProduct contains undeclared sulfites.
Apr 26, 2025Taylor Farms Illinois Inc.Foodundeclared milk
Apr 25, 2025HAWAIIAN HOST CANDIES OF LA INCFoodUndeclared almond and cashew.
Apr 25, 2025My Life IncFoodUndeclared milk allergen
Apr 24, 2025Baxter Healthcare CorporationDevicesThere is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the…
Apr 24, 2025Rocky Mountain Chocolate Factory, Inc.Foodundeclared milk allergen
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Pecan.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg and Milk.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg and Milk.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.
Apr 23, 2025NEW GRAINS GLUTEN FREE BAKERYFoodDue to printing quality, label does not declare Egg allergen clearly.
Apr 22, 2025Ethicon Endo-Surgery IncDevicesFirm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If…
Apr 22, 2025MEDLINE INDUSTRIES, LP - NorthfieldDevicesAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators…
Apr 22, 2025MEDLINE INDUSTRIES, LP - NorthfieldDevicesAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators…
Apr 22, 2025MEDLINE INDUSTRIES, LP - NorthfieldDevicesAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators…
Apr 21, 2025JJWV Marketing CorporationFoodUndeclared allergen ingredient (milk)
Apr 17, 2025Amneal Pharmaceuticals, LLCDrugsPresence of Particulate Matter
Apr 17, 2025C.R. Bard IncDevicesDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to…
Apr 17, 2025C.R. Bard IncDevicesDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to…
Apr 17, 2025C.R. Bard IncDevicesDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to…
Apr 17, 2025C.R. Bard IncDevicesDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to…
Apr 17, 2025C.R. Bard IncDevicesDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to…
Apr 16, 2025HARVEST NYC INCFoodProduct is contaminated with Listeria monocytogenes.
Apr 15, 2025Optimal Carnivore, LLCFoodPotential for contamination with salmonella.
Apr 14, 2025SAINI TRADE INCDrugsMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and…
Apr 14, 2025SAINI TRADE INCDrugsMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and…
Apr 14, 2025SAINI TRADE INCDrugsMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil…
Apr 14, 2025SAINI TRADE INCDrugsMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and…
Apr 14, 2025SAINI TRADE INCDrugsMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and…
Apr 11, 2025Centerline Biomedical IncDevicesCenterline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Apr 11, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesInadequate weld that can potentially cause the product to disassemble.
Apr 11, 2025Integra LifeSciences Corp. (NeuroSciences)DevicesInadequate weld that can potentially cause the product to disassemble.
Apr 11, 2025Medical Depot Inc.DevicesPotential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Apr 11, 2025Nipro Renal Soultions USA, CorporationDevicesPotential for the presence of visible foreign matter.
Apr 10, 20253M CompanyDevicesField action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid…
Apr 10, 2025MOMO TEA INCFoodProduct does not declare the allergen, milk, on the label.
Apr 10, 2025Smiths Medical ASD, Inc.DevicesThere is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Apr 10, 2025Smiths Medical ASD, Inc.DevicesThere is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Apr 10, 2025Smiths Medical ASD, Inc.DevicesAffected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion…
Apr 10, 2025Smiths Medical ASD, Inc.DevicesAffected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion…
Apr 10, 2025Smiths Medical ASD, Inc.DevicesPumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or…
Apr 10, 2025Vyaire MedicalDevicesAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe…
Apr 10, 2025Vyaire MedicalDevicesAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe…
Apr 7, 2025Baxter Healthcare CorporationDevicesA cybersecurity vulnerability was discovered through internal testing.
Apr 7, 2025Baxter Healthcare CorporationDevicesA cybersecurity vulnerability was discovered through internal testing.
Apr 5, 2025Trophy Nut CompanyFoodProduct mislabeled - product labeled as peanuts, but may contain cashews
Apr 4, 2025Duda Farm Fresh Foods, Inc.FoodProduct tested positive for Listeria Monocytogenes.
Apr 4, 2025Supplement Manufacturing Partner Inc.FoodUndeclared allergen: Wheat
Apr 2, 2025Caraluzzi's MarketsFoodProduct contains undeclared egg.

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.