Home / Months / May 2026

FDA Warning Letters, 483s and Recalls: May 2026

FDA enforcement records dated May 2026: 37 warning letters outside tobacco (plus 13 tobacco letters), 27 OAI inspections and 94 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

· All months ·

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
May 29, 2026Macau-Union Pharmaceutical LimitedCenter for Drug Evaluation and Research (CDER)Nonprescription/OTC
May 28, 2026Jose M. Carpio, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
May 28, 2026Jubilant HollisterStier General PartnershipCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 28, 2026Medline IncCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 27, 2026Linemaster Switch CorporationCenter for Devices and Radiological HealthCGMP/QSR/Drug/Medical Devices/Adulterated
May 27, 2026Pharmathen International S.A.Center for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
May 26, 2026AF Import & Wholesale CoOffice of Inspections and InvestigationsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 26, 2026Blue Horizon International, LLCCenter for Biologics Evaluation and Research (CBER)Unapproved New Drugs/Unlicensed Biological Product Violations
May 26, 2026Pamex Foods IncorporatedOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
May 22, 2026Aeroflex Industria De Aerosol Ltda.Center for Drug Evaluation and Research (CDER)Refusal to Provide Access to and Copying of Records
May 22, 2026Laboratorios Jaloma S.A. De C.V.Center for Drug Evaluation and Research (CDER)CGMP/OTC/Finished Pharmaceuticals/Adulterated
May 22, 2026ZIIP, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 21, 2026Alchymars ICM SM Private LimitedCenter for Drug Evaluation and Research (CDER)CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
May 20, 20263B Medical, Inc. Dba Reach Health, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
May 20, 2026Aversa's Italian BakeryHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
May 20, 2026BMC Medical Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
May 20, 2026Golden Dakota Farms LLCCenter for Veterinary MedicineNew Animal Drug/Adulterated
May 19, 2026HealthPartners Neuroscience Center Research And InnovationCenter for Drug Evaluation and Research (CDER)Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
May 19, 2026Skytron, LLCCenter for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
May 18, 2026Aja Health And Wellness Inc.Center for Drug Evaluation and Research (CDER)Nonprescription/OTC
May 18, 2026GSC Products, LLCCenter for Drug Evaluation and Research (CDER)Nonprescription/OTC
May 18, 2026Sato Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Drugs/Adulterated/OTC
May 15, 2026City Market, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
May 15, 2026Meta Labs Pharmaceuticals, LLCHuman Foods ProgramDietary Supplement/New Drug/Misbranded
May 14, 2026Bharat Overseas Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)
May 14, 2026Bushman Organic Farms, Inc.Human Foods ProgramForeign Supplier Verification Program (FSVP)
May 14, 2026GC America, Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
May 14, 2026La Crema De RebecaCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
May 14, 2026Lus Essentials LLCCenter for Drug Evaluation and Research (CDER)Unapproved New Drugs/Misbranded
May 14, 2026PolleyMed, LLCCenter for Drug Evaluation and Research (CDER)Nonprescription/OTC
May 12, 2026Dough-To-Go, Inc.Human Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
May 12, 2026Fagron BVCenter for Drug Evaluation and Research (CDER)Compounding Pharmacy/Adulterated Drug Products
May 12, 2026Flax & More CorporationHuman Foods ProgramCGMP/Dietary Supplement/Adulterated
May 4, 2026IDO Pharm Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/OTC Finished Pharmaceuticals/Adulterated
May 4, 2026Naseem A. Jaffrani, M.D.Center for Drug Evaluation and Research (CDER)Clinical Investigator
May 4, 2026Naveh Pharma LTD/Bigdam Inc.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
May 1, 2026Harbin Jixianglong Biotech Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/API/Adulterated and Misbranded Drugs

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
May 29, 2026Cosmoceutical Research Center, Inc.DrugsUnited States
May 29, 2026Northland Nuclear Medicine, LLCDrugsUnited States
May 27, 2026BEAUTY STORE LLCFood/CosmeticsUnited States
May 26, 2026Las Dos Californias IncFood/CosmeticsUnited States
May 21, 2026Oakwood Laboratories LLCDrugsUnited States
May 21, 2026Ohio Pet Foods, Inc.VeterinaryUnited States
May 20, 2026Balkanica LLCFood/CosmeticsUnited States
May 20, 2026Eherbs Imports, Inc.Food/CosmeticsUnited States
May 20, 2026Imperial Nougat CompanyFood/CosmeticsUnited States
May 19, 2026Samchundang Pharm Co., Ltd.DrugsKorea (the Republic of)
May 15, 2026Anhui Province, Lu'an City Hongyuan Food Co., Ltd.Food/CosmeticsChina
May 15, 2026MESQUITE GOURMET LLCFood/CosmeticsUnited States
May 15, 2026Mylan Laboratories LimitedDrugsIndia
May 15, 2026Owen Biosciences Inc.DrugsUnited States
May 15, 2026Unither Manufacturing LLC.DrugsUnited States
May 14, 2026Win Woo Trading LlcFood/CosmeticsUnited States
May 8, 2026Eriochem SADrugsArgentina
May 8, 2026Milchwerke "Mittelelbe" GmbHFood/CosmeticsGermany
May 8, 2026Sombra Cosmetics, IncDrugsUnited States
May 7, 2026Ruukoo International Food Market IncFood/CosmeticsUnited States
May 7, 2026Topical Pharmaceuticals, Inc.DrugsUnited States
May 5, 2026Peakopia ProduceFood/CosmeticsUnited States
May 5, 2026Performance Feeds LLCVeterinaryUnited States
May 4, 2026CTK OTC Laboratories LLCDrugsUnited States
May 4, 2026M.G.R. Produce, LLCFood/CosmeticsUnited States
May 1, 2026GVS TM, IncBiologicsUnited States
May 1, 2026SnugZ USA, 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)FSVP assurances37
21 CFR 117.35(a)Sanitary operations - Plant sanitation30
21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard18
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement17
21 CFR 1.506(b)Supplier verification - follow written procedures17
21 CFR 117.10Personnel16
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls16
21 CFR 1.505(a)(2)Evaluation - performance, risk16
21 CFR 211.192No written record of investigation16
21 CFR 123.11(b)Sanitation monitoring documentation15

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
May 29, 2026Hamilton Medical AGDevicesVentilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during…
May 28, 2026Azuma Foods International Inc USAFoodUndeclared fish.
May 28, 2026CareFusion 213, LLCDrugsNon-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding…
May 28, 2026CareFusion 213, LLCDrugsNon-Sterility: Due to presence of Aspergillus penicillioides.
May 24, 2026MOGO Moringa LLCFoodProduct may be contaminated with Salmonella Typhimurium
May 23, 2026Bazzini LLCFoodUndeclared peanuts
May 22, 2026Abiomed, Inc.DevicesPotential for thrombus formation during prolonged use of the introducer.
May 22, 2026Abiomed, Inc.DevicesPotential for thrombus formation during prolonged use of the introducer.
May 22, 2026Abiomed, Inc.DevicesPotential for thrombus formation during prolonged use of the introducer.
May 22, 2026Abiomed, Inc.DevicesPotential for thrombus formation during prolonged use of the introducer.
May 22, 2026Medtronic Heart Valves DivisionDevicesDevices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from…
May 22, 2026Total Nutrition IncFoodProduct may be contaminated with Salmonella.
May 21, 2026Baxter Healthcare CorporationDevicesThere have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage…
May 21, 2026Baxter Healthcare CorporationDevicesThere have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage…
May 21, 2026Baxter Healthcare CorporationDevicesThere have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage…
May 21, 2026Baxter Healthcare CorporationDevicesThere have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage…
May 21, 2026Windstone Medical Packaging, Inc.DevicesKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus…
May 21, 2026Windstone Medical Packaging, Inc.DevicesKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus…
May 21, 2026Windstone Medical Packaging, Inc.DevicesKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus…
May 21, 2026Windstone Medical Packaging, Inc.DevicesKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus…
May 20, 2026Hometown Food CompanyFoodUndeclared egg
May 20, 2026Insulet CorporationDevicesExternal soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user…
May 20, 2026Insulet CorporationDevicesExternal soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user…
May 20, 2026Insulet CorporationDevicesExternal soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user…
May 19, 2026Kettle Cuisine, LLCFoodContains undeclared allergen (shrimp).
May 18, 2026Abiomed, Inc.DevicesExposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss…
May 18, 2026Wilco Peanut CoFoodUndeclared Tree Nut Allergen
May 15, 2026Medline Industries, LPDevicesExpansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual…
May 14, 2026Abiomed, Inc.DevicesPotential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
May 14, 2026IQ PRODUCE, LLCFoodImported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
May 13, 2026CERELES EN GENERAL SASFoodUndeclared allergens: Milk and Soy
May 13, 2026Medical Action Industries, Inc. 306DevicesCardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has…
May 13, 2026Terra Medi LLCFoodUn-eviscerated fish may be contaminated with clostridium botulinum
May 12, 2026SUN PHARMACEUTICAL INDUSTRIES INCDrugsPresence of Particulate matter: Particulate matter identified as glass.
May 11, 2026HH FRESH TRADING CORPFoodImported Enoki Mushrooms tested positive for Listeria Monocytogenes.
May 8, 2026Datex-Ohmeda IncDevicesBlender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that…
May 8, 2026Datex-Ohmeda IncDevicesBlender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that…
May 8, 2026Datex-Ohmeda IncDevicesBlender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that…
May 7, 2026Draeger, Inc.DevicesThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical…
May 7, 2026Draeger, Inc.DevicesThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical…
May 6, 2026B Braun Medical IncDevicesThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has…
May 6, 2026B Braun Medical IncDevicesThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has…
May 6, 2026B Braun Medical IncDevicesThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has…
May 6, 2026Fresenius Kabi USA, LLCDevicesPotential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion…
May 6, 2026Fresenius Kabi USA, LLCDevicesFresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal…
May 6, 2026Medline Industries, LPDevicesThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride…
May 6, 2026Medline Industries, LPDevicesThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride…
May 6, 2026Medline Industries, LPDevicesThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride…
May 6, 2026Medline Industries, LPDevicesThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride…
May 6, 2026The Coffee Connexion Co., IncFoodProduct contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
May 6, 2026The Coffee Connexion Co., IncFoodProduct contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
May 6, 2026The Coffee Connexion Co., IncFoodProduct contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
May 6, 2026The Coffee Connexion Co., IncFoodProduct contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
May 5, 2026Coco G's Snack Foods, Inc.FoodPotential Salmonella contamination.
May 5, 2026Guittard Chocolate CompanyFoodPotential contamination with Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026JOHN B SANFILIPPO & SONS INCFoodpotential presence of Salmonella
May 5, 2026Legacy Bakehouse LLCFoodProducts were made with recalled California Dairies milk powder due to Salmonella.
May 5, 2026Legacy Bakehouse LLCFoodProducts were made with recalled California Dairies milk powder due to Salmonella.
May 5, 2026Legacy Bakehouse LLCFoodProducts were made with recalled California Dairies milk powder due to Salmonella.
May 5, 2026Stoltzfus Family Dairy LLCFoodProduct may be contaminated with Salmonella.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026D'Dioses Fruit Pops, Inc.FoodMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May 4, 2026Jonco IndustriesFoodProducts were made with recalled California Dairies milk powder due to Salmonella.
May 4, 2026KAYSERBETTEN GMBH & CO. KGDevicesIf the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child)…
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026JCB Flavors, LLCFoodProducts may be potentially contaminated with Salmonella.
May 1, 2026The A2 Milk CompanyFoodPossible contamination with Cereulide toxin.

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.