FDA Recalls, Market Withdrawals, & Safety Alerts

 
DateBrand-NamesProduct-DescriptionProduct-TypesRecall-Reason-DescriptionCompany-NameTerminated Recall
09/29/2022Golden State Medical Supply, IncorporatedClopidogrel 75mg Tablets, Atenolol 25mg TabletsDrugsDue to Label Mix-upGolden State Medical Supply, Incorporated
10/13/2022Exela & CivicaSodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vialDrugsVial BreakageExela Pharma Sciences, LLC
10/24/2022WatchCareIncontinence management systemMedical DevicesPotential for radio frequency (RF) interference with other medical devices.Baxter International Inc.
10/24/2022Mighty BlissHeating padsMedical DevicesUse of product may lead to burns, mild shocks, or rashes and irritationWhele LLC
10/25/2022Aurobindo Pharma USA, Inc.Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottleDrugsDue to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-QuinaprilAurobindo Pharma USA, Inc.
11/04/2022Gibeck® and Iso-Gard®Bacterial and viral filtersMedical DevicesFilter may split or detach during useTeleflex Incorporated
11/05/2022Insulet Corporation Omnipod DASHPersonal Diabetes ManagersMedical DevicesBattery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.Insulet Corporation
11/07/2022Adam’s PolishesHand sanitizerDrugsPresence of methanolAdam’s Polishes, LLC
11/15/2022Insulet Corporation OmnipodAutomated Insulin Delivery SystemMedical DevicesIssue with the Omnipod 5 Controller charging port and cableInsulet Corporation
11/29/2022ExelaSodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vialDrugsVial BreakageExela Pharma Sciences, LLC
05/02/2022FagronSyrSpend SF 500mL and 4LDrugsPotential contamination with Burkholderia gladioliFagron Inc.
05/02/2022Philips RespironicsV60/V60 Plus, and V680Medical DevicesA potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarmPhilips Respironics
05/23/2022TevaAnagrelide CapsulesDrugsDissolution Test FailureTeva Pharmaceuticals USA
06/02/2022VolaraVolara System (home care)Medical DevicesPossible risk of oxygen desaturationBaxter International Inc.
06/07/2022Allergy Bee Gone for KidsNasal Swab RemedyDrugsProduct contains elevated levels of Bacillus cereusBuzzagogo Inc.Terminated
06/08/2022MajorMilk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral SuspensionDrugsDue to microbial contaminationPlastikon Healthcare, LLC
06/14/2022Arti KingArtri King Reforzado con Ortiga y Omega 3DrugsUndeclared Diclofenac and DexamethasoneLatin Foods Market
06/22/2022CVS HealthMagnesium Citrate Saline Laxative Oral Solution, Lemon FlavorDrugsMicrobial contamination with Gluconacetobacter liquefaciensVi-Jon, LLC
06/22/2022BDIntraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered DriversMedical DevicesProduct issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuriesBD
08/03/2022Launch SequenceLaunch Sequence Aphrodisia and Euphoria CapsulesDrugsContain TadalafilLoud Muscle Science, LLCTerminated
07/06/2022Mylan Pharmaceuticals Inc.Insulin Glargine (Insulin glargine-yfgn) Injection PensDrugsPotential for the label to be missing on some pens.Mylan Pharmaceuticals Inc.
07/13/2022HospiraPropofol Injection Emulsion, USPDrugsPotential presence of visible particulateHospira Inc, A Pfizer Company
07/15/2022Multiple brand namesMagnesium Citrate Saline Laxative Oral Solution, Lemon FlavorDrugsMicrobial contamination with Gluconacetobacter liquefaciensVi-Jon, LLC
02/21/2023nanoMaterials Discovery CorporationHand SanitizerDrugsDue to presence of methanolnanoMaterials Discovery Corporation
02/24/2023Delsam Pharma’sArtificial Eye OintmentDrugsDue to possible microbial contaminationGlobal Pharma Healthcare
03/02/2023ApotexBrimonidine Tartrate Ophthalmic Solution, 0.15%DrugsPotential lack of sterility.Apotex Corp.
03/03/2023Purely Soothing15% MSM DropsDrugsNon-sterilityPharmedica USA LLC
03/10/2023Life2000Life2000 Ventilation SystemMedical DevicesPotential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentratorBaxter International Inc.
03/22/2023Ascend LaboratoriesDabigatran Etexilate Capsules, USPDrugsDetection of N-nitroso-dabigatran (NDAB) ImpurityAscend Laboratories LLC.
03/28/2023Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDSAlcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile SolutionDrugsDue to Presence of MethanolJarman’s Midwest Cleaning Systems, Inc.
03/31/2023CamberAtovaquone Oral SuspensionDrugsPotential Bacillus cereus ContaminationCamber Pharmaceuticals, Inc.
04/03/2023AbbottReaders in the FreeStyle Libre product family.Medical DevicesPotential for battery swelling and overheating.Abbott
07/26/2022Multiple BrandsMagnesium Citrate Saline Laxative Oral SolutionDrugsPotential Gluconacetobacter liquefaciens contaminationVi-Jon, LLC
07/29/2022Banana BoatHair & scalp sunscreen sprayDrugsDue to presence of benzeneEdgewell Personal Care Company
08/02/2022SANGTERSANGTER Energy Supplement, 3000mgDrugsUndeclared SildenafilDistributor RFR, LLC
08/04/2022MajorMilk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral SuspensionDrugsMicrobial contaminationPlastikon Healthcare, LLC
08/04/2022Multiple brand namesMagnesium Citrate Saline Laxative Oral SolutionDrugsMicrobial contamination with Gluconacetobacter liquefaciensVi-Jon, LLC
02/02/2023EzriCare & Delsam PharmaArtificial Tears Lubricant Eye DropsDrugsPotential microbial contaminationGlobal Pharma Healthcare
08/22/2022HospiraPropofol Injection Emulsion, USPDrugsPotential presence of visible particulateHospira, Inc., a Pfizer Company
04/26/2023Pro Power Knight Plus, NUX, Dynamite SuperMale enhancement capsulesDrugs, Over-the-Counter DrugsProduct contains undeclared tadalafil and sildenafilGadget Island, Inc.
04/28/2023Mayne Pharma Inc.FENTANYL Buccal Tablets CIIDrugsSafety updates were omitted in the Product Insert/Medication Guide (MG)Teva Pharmaceuticals USA
05/04/2023AdvilOver-The-Counter DrugsDrugs, Over-the-Counter DrugsProduct was stored outside of labeled temperature requirements.Family Dollar
05/12/2023Walnut.Wearable Smart ThermometerMedical DevicesPotential for injuries, including skin burns & irritationBearCare, Inc
05/19/2023G-SUPRESS DXCough Suppressant, expectorant, nasal decongestant pediatric dropsDrugs, Over-the-Counter DrugsPackaging may contain incorrect productNOVIS PR LLC
05/19/2023G-SUPRESS DXCough Suppressant, expectorant, nasal decongestant pediatric dropsDrugs, Over-the-Counter DrugsDevice & Drug Safety/MislabelingNOVIS PR LLC
09/27/2022AuromedicsAcyclovir Intravenous ProductDrugsPresence of a dark red, brown and black particulate inside the vialEugia US LLC
09/28/2022My Stellar LifestyleWonder Pill CapsulesDrugsProduct contains undeclared tadalafilProper Trade LLC/My Stellar Lifestyle
12/12/2022DetectOver the counter Covid-19 TestMedical Devices, Laboratory TestsThere is an increased chance that the tests from the lot numbers listed below may give false negative resultsDetect, Inc.
12/27/2022AccordDaptomycin for InjectionDrugsMislabelingAccord Healthcare, Inc
12/27/2022Hospira, Inc.Vancomycin InjectionDrugsPresence of Visible Glass ParticulatesHospira, Inc.
12/27/2022Multiple brand namesAfter Burn® Cream and First Aid Kits containing After Burn CreamDrugsProduct is contaminated with Bacillus licheniformis and Bacillus sonorensis.GFA Production
01/09/2023SpectrumEpinephrine bulk APIDrugsProduct discolorationSpectrum Laboratory Products Inc.
09/08/2021AzurityFirvanqDrugsProduct kit may contain incorrect diluent.Azurity Pharmaceuticals, Inc.Terminated
09/13/2021Ruzurgi®Ruzurgi® (amifampridine) 10 mg tabletsDrugsExceeds Specification for Total Yeast and Mold CountsJacobus Pharmaceutical Company Inc.Terminated
10/14/2021LupinIrbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mgDrugsAPI batches above the specification limit for the impurity, N-nitrosoirbesartanLupin Pharmaceuticals, Inc.Terminated
04/28/2021Ulta Beauty Collection & SSScented Hand SanitizerDrugsPresence of Methanol (Wood Alcohol), Benzene and AcetaldehydeScentsational Soaps & Candles, Inc.Terminated
09/01/2020Red-ERed-E male enhancement tabletDrugsProduct contains undeclared sildenafilThe Protein Shoppe, LLCTerminated
09/17/2020NP Thyroid 15 & NP Thyroid120Thyroid TabletsDrugsSub PotencyAcella Pharmaceuticals, LLCTerminated
11/09/2020LohxaChlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol freeDrugsMay be contaminated with Burkholderia lataLohxa, LLCTerminated
11/19/2020Fresenius Kabi USADexmedetomidine HCL in 0.9% Sodium Chloride InjectionDrugsCross Contamination with LidocaineFresenius Kabi USATerminated
01/11/2021LOTUS Edge™ Aortic Valve SystemLOTUS Edge™ Aortic Valve SystemMedical DevicesDelivery System Issues Potential inability to release the delivery systemBoston Scientific CorporationTerminated
01/28/2021WahlDeluxe Heat Therapy Massagers, Model 4212Medical DevicesCan overheat causing smoke or spark, which may pose a fire hazardWahl Clipper CorporationTerminated
02/16/2021Adam’s SecretAdam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsulesDrugsProduct contains undeclared sildenafil and/or tadalafilAdamssecret.coTerminated
03/24/2021AlembicTelmisartan Tablets, USP, 20 mgDrugsIncorrect Product Strength on LabelAlembic Pharmaceuticals, Inc.Terminated
03/24/2021DurisanAntimicrobial Hand SanitizerDrugsDue to microbial contaminationSanit Technologies LLC d/b/a DurisanTerminated
03/29/2021Thumbs Up 7Dietary Supplement for male sexual enhancementDrugsUndeclared Sildenafil and TadalafilAntoto-KTerminated
09/21/2021IntegraDose Compounding Services, LLCCefazolinDrugs, Pharmaceutical QualityLack of sterility assurance.IntegraDose Compounding Services, LLCTerminated
07/01/2021TevaTopotecan Injection 4 mg/4 mL (1 mg/mL)DrugsPresence of particulate matterTeva PharmaceuticalsTerminated
02/18/2022SIGMA Spectrum V8 and Spectrum IQSpectrum V8 and Spectrum IQ infusion pumpsMedical DevicesPotential for alarm malfunctionBaxter International Inc.
03/03/2022B. Braun Medical Inc.0.9% Sodium Chloride for Injection USP 250ML in ExcelDrugsFluid leakage and low fill volume may cause a lack in sterilityB. Braun Medical Inc.Terminated
03/07/2022Tennessee Technical Coatings Corp.Hand SanitizerDrugsProduct contains methanolTennessee Technical Coatings Corp.
03/10/2022Olympia PharmaceuticalsCompounded InjectablesDrugsProducts are out of specificationOlympia Pharmacy
03/11/2022Flowflex™SARS-CoV-2 Antigen Rapid Test (Self-Testing)Medical Devices, CounterfeitUnauthorized U.S. distribution-counterfeited productACON Laboratories, Inc.
03/22/2022SandozOrphenadrine Citrate 100 mg Extended Release (ER) TabletsDrugsPresence of a Nitrosamine ImpuritySandoz, Inc.
03/22/2022Adamis Pharmaceuticals CorporationSYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose SyringesDrugsPotential clogging of the needle preventing the dispensing of epinephrineAdamis Pharmaceuticals CorporationTerminated
03/22/2022Accuretic, Greenstone BrandAccuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tabletsDrugsPresence of a nitrosamine, N-nitroso-quinaprilPfizer
03/24/2022Major PharmaceuticalsMagnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mLDrugsMicrobial ContaminationPlastikon Healthcare, LLC
04/01/2022F&S Medical Supply, dba Pink ToyzPink Pussycat CapsulesDrugsUndeclared SildenafilF&S Medical Supply, dba Pink Toyz
04/01/2022Mickey Mouse, The MandalorianHand SanitizerDrugsPresence of Methanol in Mickey Mouse and Presence of Benzene in The MandalorianBest Brands Consumer Products, Inc.
08/06/2021KVK Tech, Inc.Atovaquone Oral Suspension, USP 750 mg/5mLTemperature abuseKVK Tech, Inc.Terminated
08/10/2021SterRx, LLCSodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mLDrugsDue to waterborne microbial contaminationSterRx, LLCTerminated
12/03/2021GileadVeklury® (remdesivir 100 mg for injection)DrugsPresence of glass particulatesGilead Sciences Inc.Terminated
12/10/2021Rompe PechoLiquid Cold & Flu symptom reliefDrugsMicrobial contaminationEfficient Laboratories, IncTerminated
01/12/2022VionaMetformin Hydrochloride Extended-Release TabletsDrugsN-Nitrosodimethylamine (NDMA) ImpurityViona Pharmaceuticals, Inc.Terminated
01/12/2022OscorDestino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheathMedical DevicesHub cap and seal on the proximal end of the device handle may detach during useOscor Inc.
01/12/2022AVpakSenna Syrup 5mLDrugsPotential microbial contaminationLohxa LLCTerminated
01/27/2022RevitaDermWound Care GelDrugsMay be contaminated with Bacillus cereusBlaine Labs Company
01/31/2022Hard DawnHard Dawn Rise and Shine capsulesDrugsUndeclared TadalafilEsupplementsales, LLC
02/04/2022MegManMegMan Performance Booster capsulesDrugsUndeclared TadalafilJunp LLC
02/04/2022bellavista™ventilatorsMedical DevicesVentilators can cease ventilation and generate a technical failure alarm 305Vyaire Medical
02/04/2022SD Biosensor, Inc.STANDARD Q COVID-19 Ag Home TestMedical Devicesillegally imported into the United StatesSD Biosensor, Inc.
02/08/2022Your Favorite ShopThe Red PillDrugsUndeclared TadalafilYour Favorite ShopTerminated
02/08/2022MAC DADDYMAC DADDY RED and PURPLE DIETARY SUPPLEMENTSDrugsUndeclared Sildenafil and/or TadalafilABC SALES 1 INCTerminated
02/09/2022Celebrate TodayRed Mammoth capsulesDrugsUndeclared Sildenafil and TadalafilCelebrate Today
02/10/2022Positive-HealthRise Up Red Edition CapsulesDrugsUndeclared TadalafilPositive-HealthTerminated
10/27/2021artnaturalsScent Free Hand SanitizerDrugsDue to Presence of Impuritiesartnaturals
08/10/2020(Becton, Dickinson and Company)ChloraPrep™ 3 mL applicatorDrugsPotential fungal contamination - Aspergillus penicillioides(Becton, Dickinson and Company)Terminated
09/03/2020LeafreeHand sanitizerDrugsProduct is labeled as edible alcohol.CorgioMed LLCTerminated
03/26/2020Dr. Reddy’s Laboratories Ltd.Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose AmpulesDrugsAmpules breaking & shatteringDr. Reddy’s Laboratories Ltd.Terminated
07/22/2020Fresenius KabiDexmedetomidine Hydrochloride Injection, 200 mcg/50 mLDrugsCross contamination with lidocaineFresenius Kabi USATerminated
12/02/2020MPM MedicalRegenecare HA Topical Anesthetic HydrogelDrugsBurkholderia cepecia contamination.MPM Medical, LLCTerminated
04/16/2020HeritageTetracycline HCl Capsules, 250mg and 500mgDrugsDue to low out of specification dissolution resultsAvet Pharmaceuticals Labs Inc.Terminated
03/31/2021Thumbs Up 7, Shogun, Krazy NightDietary Supplement for male sexual enhancementDrugsUndeclared Sildenafil, Tadalafil, VardenafilUmmzy LLCTerminated
03/17/2020OscorTemporary Bipolar Pacing LeadsMedical DevicesThe connector cap housing may slide and potentially expose the connection wireOscor Inc.Terminated
11/08/2019AHPRanitidine Liquid Unit Dose CupsDrugsNDMA (Nitrosodimethylamine) impurityAmerican Health PackagingTerminated
11/19/2019PrecisionDoseRanitidine Oral Solution, USP 150 mg/10 mLDrugsPotential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDAPrecision Dose Inc.Terminated
03/23/2020Ranier's RX LaboratoryCompounded drug productsDrugs, Generic DrugsDue to Lack of Sterility AssuranceRanier's RX LaboratoryTerminated
03/19/2020Beaumont Bio Med HomeopathicHomeopathic oral spraysDrugs, Generic DrugsDue to Possible Microbial ContaminationBeaumont Bio Med, Inc.Terminated
03/27/2020TaytullaBirth control capsulesDrugs, Over-the-Counter DrugsDue to Out of Sequence CapsulesAllerganTerminated
03/24/2020Sonic-FusionFlossing toothbrushMedical Devices, DentalCharging base may overheatWater Pik, IncTerminated
02/04/2019Dr. Reddy’s Laboratories Ltd.Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection)Drugs, Generic DrugsMislabelingDr. Reddy’s Laboratories Ltd.Terminated
03/17/2020Zero XtremeDietary Supplement for Weight LossDrugsDue to Presence of Undeclared SibutramineFat Burners ZoneTerminated
01/29/2019CVS, EquateOral ibuprofenDrugs, Generic DrugsHigher Concentration of IbuprofenTris Pharma, Inc.Terminated
03/16/2020PuritonPuriton Eye Relief Drops, 0.5 oz. (15ml) bottleDrugs, Over-the-Counter DrugsDue to Non-Sterile Production ConditionsKadesh Inc.Terminated
02/08/2018Baxterintravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USPDrugsLabeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tabletsBaxter International Inc.Terminated
02/08/2018Bristol-Myers SquibbEliquis (apixaban) 5 mg TabletsDrugsPotential Labeling IssueBristol-Myers SquibbTerminated
09/12/2017MedtronicInfusion setsMedical DevicesA component may be susceptible to being blocked by fluidMedtronic
02/08/2018Amneal Pharmaceuticals LLCLorazepam Oral Concentrate, USP 2mg/mLDrugsDue to Misprinted Dosing DroppersAmneal Pharmaceuticals LLCTerminated
07/07/2020MylanDaptomycin for InjectionDrugsPresence of particulate matterMylan Institutional LLCTerminated
07/28/2020KORE ORGANICWatermelon CBD oil tinctureDrugsContains leadSummitt LabsTerminated
05/22/2020Acella30-mg, 60-mg and 90-mg NP Thyroid®DrugsSuper potencyAcella Pharmaceuticals, LLCTerminated
06/18/2020RobitussinCough and cold productsDrugs, Over-the-Counter DrugsIncorrect dosing cupsGSK Consumer HealthcareTerminated
07/07/2023CiplaAlbuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)DrugsFailure to deliver the recommended doseCipla
08/26/2023Dr. Berne’sMSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% SolutionDrugsBacterial and Fungal ContaminationDr. Berne’s Whole Health Products
09/07/2021HospiraAminosyn II, 15%, An Amino Acid Injection, SulfiteDrugsPresence of visible particulate matterICU Medical, Inc.Terminated
09/23/2019Sandoz Inc.Ranitidine Hydrochloride CapsulesDrugsDue to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)Sandoz Inc.Terminated
05/11/2021PoseidonMale Sexual Enhancement Dietary SupplementDrugsUndeclared Tadalafil and SildenafilYamtun7Terminated
07/31/2023SIGMA Spectrum and Spectrum IQInfusion pumpsMedical DevicesDue to an increase in reported false upstream occlusion alarms following the software upgrades.Baxter International Inc.
02/10/2023Skippack Medical Lab, DiagnosUsSARS-CoV-2 Antigen Rapid Test KitsMedical DevicesProducts were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.Universal Meditech Inc.
06/09/2022SnoreStopNasal sprayDrugsDue to microbial contamination identified as Providencia rettgeri.Green Pharmaceuticals IncTerminated
08/04/2023DrägerCarina Sub-Acute Care VentilatorsMedical DevicesProduct Safety/Potential Foreign MaterialDrägerwerk AG & Co. KGaA
07/31/2023Lupin Pharmaceuticals, Inc.Tydemy oral contraceptiveDrugsOut of Specification ResultsLupin Pharmaceuticals, Inc.
12/18/2023No BrandVigabatrin for Oral Solution, USP 500mgDrugsDue to seal integrity issues allowing for powder leakage from the pouch.InvaGen Pharmaceuticals Inc.
11/14/2023Multiple brandsDietary Supplements with undeclared DiclofenacDrugsUndeclared drug, DiclofenacBotanical-Be
10/02/2023Hospira4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USPDrugsPotential Presence of Glass ParticulatesHospira, Inc.
10/03/2023KVK TechBetaxolol Tablets, USPDrugsPotential Presence of Oxycodone HCl tabletKVK-Tech, Inc.
02/01/2023IBSATIROSINT®-SOL (levothyroxine sodium)DrugsSubpotencyIBSA Pharma Inc.Terminated
09/08/2023TheraBreathTheraBreath Kids Strawberry Splash Oral RinseDrugsDevice & Drug Safety/Microbial ContaminationChurch & Dwight Co., Inc.
03/07/2022Fresenius Kabi USASodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vialDrugsDue to the presence of particulate matter found in reserve and/or stability sample vialsFresenius Kabi, USATerminated
12/27/2021PerrigoNitroglycerin Lingual SprayDrugsUnit may not properly dispense medication.PadagisTerminated
10/02/2023Ion and Restore brandsNasal SpraysDrugsPotential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp.Biomic Sciences
11/27/2023NovartisSandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mLDrugsDue to crystallization formationNovartis Pharmaceuticals Corporation
11/24/2023TING®2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowderDrugsPresence of benzeneInsight Pharmaceuticals
12/30/2021TaroClobetasol PropionateDrugsPresence of Ralstonia pickettii bacteriaTaro Pharmaceuticals USA, Inc.Terminated
11/30/2023BaxterNovum IQ syringe infusion pump.Medical DevicesPotential for an incomplete infusion following one or more downstream occlusion alarms.Baxter International, Inc.
05/11/2020MasterPharm, LLCFinasteride Plus 1.25mg, capsulesDrugsContains undeclared minoxidilMasterPharm, LLCTerminated
09/28/2023BrexafemmeAntifungal oral medicationDrugsPotential cross contamination with non-antibacterial beta-lactam drug substanceScynexis, Inc.
09/22/2023Healthy Wiser and moreTest kitsMedical DevicesProduct Safety/DefectUniversal Meditech Inc.
08/31/2023Healthy Wiser and moreTest kitsMedical DevicesDue to lack of appropriate premarket clearance or approval which potentially could result in inaccurate test resultsUniversal Meditech Inc.
01/08/2020NorthwindRanitidine Tablets 150mg and 300mgDrugsNDMA (Nitrosodimethylamine) impurityDenton Pharma, Inc. dba Northwind PharmaceuticalsTerminated
09/03/2020bio aaaHand SanitizerDrugsPossible presence of methanolAJR Trading LLCTerminated
03/17/2021Heal the WorldHand SanitizerDrugsBecause they resemble water bottles; risk of ingestionPNHC, LLC d/b/a Heal the WorldTerminated
06/22/2021Prairie Wolf DistilleryHand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottlesDrugsPackaged in containers resembling water bottlesPrairie Wolf Spirits, Inc.Terminated
12/09/2020AvKareSildenafil 100 mg tablets and Trazodone 100mg tabletsDrugsDue to product mix-upAvKareTerminated
07/25/2022SustangoDietary Supplement for Male EnhancementDrugsUndeclared TadalafilUltra Supplement LLCTerminated
10/25/2023Exela and Civica BrandsSodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection ELCYS (cysteine hydrochloride Injection), USPDrugsPotential presence of particulate matterExela Pharma Sciences, LLC
03/16/2018BayerAlka-Seltzer PlusDrugsBayerTerminated
01/24/2018Basic DrugsSenna LaxativeDrugsMagno-Humphries Laboratories, Inc.Terminated
01/10/2018International Laboratories, LLCClopidogrel Tablets USP, 75 mgDrugsInternational Laboratories, LLCTerminated
09/11/2023NovartisSandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mLDrugsCrystal formation which could potentially result in incorrect dosingNovartis Pharmaceuticals Corporation
11/01/2023LEADEROTC Ophthalmic Sterile DropsDrugsInsanitary manufacturing conditionsCardinal Health, Inc.
11/06/2023Multiple brand names0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USPMedical DevicesLack of sterility assuranceNurse Assist, LLC
04/12/2022MylanInsulin Glargine (Insulin glargine-yfgn) InjectionDrugsLabel may be missing on some vialsMylan Pharmaceuticals, Inc. a Viatris CompanyTerminated
09/02/2021Meridian Bioscience, Inc.LeadCare® Test KitsMedical DevicesLeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samplesMeridian Bioscience, Inc.Terminated
11/21/2023Noah’s Wholesale, LLCDietary Supplement with undeclared SildenafilDrugsUndeclared drug, SildenafilNoah’s Wholesale, LLC
11/17/2023KinderMedOTC Pain and Fever Reliever for Infants and KidsDrugsDue to Acetaminophen InstabilityKinderFarms, LLC
11/21/2023BayerVitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottlesDrugsMicrobial contamination identified as Penicillium brevicompactumBayer
11/01/2023RugbyOTC Ophthalmic Sterile DropsDrugsInsanitary manufacturing conditionsThe Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
12/21/2023ResMedMasks with magnetsMedical DevicesPotential for magnetic interference near certain implants and medical devicesResMed
01/08/2021Fresenius KabiKetorolac Tromethamine Injection, USP, 30 mg/mLDrugsPresence of particulate matterFresenius Kabi USATerminated
07/19/2022Dose VitalHoneyDrugsUndeclared active pharmaceutical ingredient tadalafilMKS Enterprise LLCTerminated
10/01/2021Lotrimin® AF and Tinactin®Over the Counter (OTC) antifungal spray productsDrugsPresence of benzeneBayer U.S. LLCTerminated
03/29/2022Teva PharmaceuticalsIDArubicin Hydrochloride Injection USPDrugsPotential Particulate Matter (silica and iron oxide)Teva PharmaceuticalsTerminated
12/22/2023No BrandBleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop VialDrugsPresence of Glass Particulate MatterHospira, Inc.
12/22/2023AmericaineBenzocaine Topical Anesthetic SprayDrugsPresence of benzeneInsight Pharmaceuticals
01/08/2024Leiters, Compounding HealthVancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV BagsDrugsPotential for superpotent drugLeiters Health
07/18/2019AlarisAlaris Pump Module Model 8100 and Certain Alaris Pump Infusion SetsMedical DevicesWeakening of the plastic can lead to damage or separation of the bezel posts which can cause issues with infusion, or unintended delivery of medication when pump module is not in running statusBDTerminated
12/26/2023Hospira4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injectionDrugsPresence of Glass Particulate MatterHospira, Inc.
01/19/2022SemgleeInsulin glargine injection), 100 units/ml (U-100), 3mL prefilled pensDrugsMissing LabelMylan Pharmaceutical Inc.Terminated
10/25/2022Mylan Institutional LLCOctreotide Acetate Injection, 500 mcg/mLDrugsDue to glass particulatesMylan Institutional LLC, a Viatris companyTerminated
01/24/2024RobitussinCough syrupsDrugsMicrobial ContaminationHaleon
11/15/2023Multiple brandsLubricant Eye Drops & Multi-Symptom Eye DropsDrugsDevice & Drug Safety Potential Safety ConcernsKilitch Healthcare India Limited
01/22/2024Multiple brandsLubricant Eye Drops & Multi-Symptom Eye DropsDrugsDevice & Drug Safety Potential Safety ConcernsKilitch Healthcare India Limited
01/29/2024Neptune’s FixNeptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix TabletsDrugsUndeclared TianeptineNeptune Resources, LLC
01/04/2024AtriumExpress DrainsMedical DevicesSyringes provided with Express Drains could not be verified to be sterile.Getinge/Atrium Medical Corporation
02/02/2024TING®1% Tolnaftate Athlete’s Foot Spray Antifungal Spray LiquidDrugsPresence of benzeneInsight Pharmaceuticals
02/05/2024Sustain, SchwinnngSustain and Schwinnng brand male enhancement capsulesDrugsProducts contain undeclared Tadalafil and NortadalafilToday the World
02/05/2024ArizeArize brand male enhancement capsulesDrugsProducts contain undeclared NortadalafilToday the World
01/30/2023Banana BoatHair & Scalp Spray SPF 30DrugsDue to presence of benzeneEdgewell Personal CareTerminated
02/29/2024MegadyneMega Soft Universal and Universal Plus Reusable Patient Return ElectrodesMedical DevicesLimit use to patients aged 12 years or older.Megadyne Medical Products, Inc.
10/05/2020Time-Cap Labs Inc.Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mgDrugsDue to the Detection of N-Nitrosodimethylamine (NDMA) ImpurityMarksans Pharma LimitedTerminated
10/19/2021Cook MedicalTransseptal Needle and Transseptal Needle CatheterMedical DevicesComplaints of rust on the productsCook MedicalTerminated
10/02/2020Smart CareHand sanitizer packaged in 0.84 oz. pouchesDrugsProduct is packaged in containers resembling a food and drink pouchAshtel StudiosTerminated
03/12/2024Par PharmaceuticalTreprostinil 20mg/20mL InjectionDrugsPotential Presence of Silicone Particulate MatterEndo International, Par Pharmaceutical
02/26/2024Multiple brandsEye ointment productsDrugsDue to Potential Lack of Sterility Assurance.Brassica Pharma Pvt. Ltd.
04/01/2024AVpakAtovaquone Oral Suspension, USP 750mg/5mLDrugsPotential Bacillus cereus contaminationAvKARE, LLC
06/29/2022Bryant Ranch Prepack Inc.Morphine Sulfate 30 mg Extended-Release tabletsDrugsIncorrect labelingBryant Ranch Prepack Inc.Terminated
04/05/2024Aruba AloeHand Sanitizer Gel and Alcoholada GelDrugsProduct contains methanolAruba Aloe Balm N.V.
04/05/2024Fendall 2000Non-Sterile Eyewash CartridgeDrugsNon-compliance with current good manufacturing practice (cGMP) requirements.Honeywell Safety Products USA
03/18/2024Mojo, Mojo 2, iQ 2, Phantom 2CPAP and BIPAP Masks with MagnetsMedical DevicesPotential interference with certain medical implantsSleepnet Corporation
03/20/2024NimbusNimbus Pump SystemMedical DevicesRecall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systemsInfuTronix, LLC
03/28/2024Eugia US LLCMethocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)DrugsDevice & Drug Safety – Presence of Particulate MatterEugia US LLC
03/27/2024AmnealVancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mLDrugsSuper potent due to bottles being overfilledAmneal Pharmaceuticals, LLC.
09/01/2020AlarisAlaris Infusion PumpMedical DevicesHardware issues may cause the infusion pump to not operate as expectedBecton, Dickinson and CompanyTerminated
08/31/2023Marlex Pharmaceuticals, Inc.Digoxin Tablets USP, 0.125mg and 0.25mgDrugsLabel Mix-UpMarlex Pharmaceuticals, Inc.Terminated
04/23/2024SchwinnngHerbal Dietary SupplementDrugsProduct is tainted with NortadalafilSTOP CLOPEZ CORP
04/23/2024Dr. Reddy’sSapropterin Dihydrochloride Powder for Oral Solution 100 mgDrugsDecreased PotencyDr. Reddy’s Laboratories Inc
05/10/2024Ethicon MegadyneMega Soft Pediatric Patient Return ElectrodeMedical DevicesReports of patient burn injuriesMegadyne Medical Products Inc.
07/08/2020OvationOvation iX systemMedical DevicesA material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.Endologix® Inc.Terminated
09/22/2023VistaPharmSucralfate Oral Suspension 1g/10mLDrugsPotential contamination with Bacillus cereusPotential contamination with Bacillus cereusTerminated
06/05/2024StellaLife Inc.Homeopathic StellaLife Oral Care ProductsDrugsMicrobial contaminationHomeoCare Laboratories Inc.
05/31/2024MedlineSubG Endotracheal Tubes with Subglottic Suction and kits that contain these devicesMedical DevicesThe inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate.Medline Industries LP
06/26/2024Blue Point LaboratoriesPotassium Chloride Extended Release 750mg Capsules, 100 count and 500 countDrugsFailed dissolutionAmerican Health Packaging
08/07/2020Gelbac TAntibacterial HandgelDrugsMethanol ContaminationIncredible Products Sa de CvTerminated
06/12/2024SuntegritySunscreen foundationDrugsHigher than acceptable microbiological mold countSuntegrity Skincare
06/14/2023Major PharmaceuticalsDronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mgDrugsPackaging may contain incorrect product due to labeling mix-upThe Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby LaboratoriesTerminated
07/15/2024UmaryUmary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mgDrugsTainted with the drug ingredients, diclofenac and omeprazoleSoloVital.com
07/16/2024VolaraVolara system single-patient use circuit and blue ventilator adapter assemblyMedical DevicesReports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapterBaxter International Inc.
07/22/2024UmaryUmary Acido Hialuronico, Suplemento AlimenticioDrugsUndeclared Drug Ingredients: Diclofenac and OmeprazoleMain Products, Inc.
07/24/2024Healthy LivingMigraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tabletsDrugsDevice & Drug Safety - MislabelingAurobindo Pharma USA, Inc.
07/22/2024HikmaAcetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mLDrugsPotential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).Hikma Pharmaceuticals PLC
07/31/2024AbbottFreeStyle Libre® 3 sensorsMedical DevicesSensors may provide incorrect high glucose readingsAbbott
08/06/2024BaxterHeparin Sodium in 0.9% Sodium Chloride InjectionDrugsElevated endotoxin levelsBaxter International Inc
06/11/2019GSMS Inc.Losartan potassium tabletsDrugs, Generic DrugsDetection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)Teva Pharmaceuticals USA, Inc.Terminated
06/05/2020ActavisMetformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mgDrugsDue to detection of N-Nitrosodimethylamine (NDMA)Teva Pharmaceuticals USA Inc.
08/31/2020Always Be Clean, JustHand SanitizerDrugsProducts labeled to contain methanolOpen Book Extracts
08/28/2020Harmonic NatureHand sanitizerDrugsProduct contains 1 propanolHARMONIC NATURE S. DE R.L. Mi
07/08/2020LupinMetformin Hydrochloride Extended-Release Tablets, 500mg and 1000mgDrugsN-Nitrosodimethylamine (NDMA) ImpurityLupin Pharmaceuticals, Inc.Terminated
09/23/2020Riomet ERMetformin Hydrochloride for Extended-Release Oral SuspensionDrugsDue to the Detection of N-Nitrosodimethylamine (NDMA) ImpuritySun Pharmaceutical IndustriesTerminated
08/12/2024TandemT:Connect Mobile App for iOS DevicesMedical DevicesRapid Depletion of a User’s t:slim X2 Insulin Pump BatteryTandem Diabetes Care, Inc.
08/08/2024B Braun0.9% Sodium Chloride for Injection USP 1000 mL in E3 containersDrugsPotential for particulate matter and fluid leakage of the containersB. Braun Medical Inc.
08/04/2020Command BrandsHand SanitizerDrugsMethanol ContaminationRoque Plast S.A. de C.V.Terminated
07/14/2020BersihHand Sanitizer GelDrugsPotential Methanol ContaminationSoluciones CosmeticasTerminated
09/06/2022PhilipsCertain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or strapsMedical Devicespotential risk of serious injuryRoyal Philips’ subsidiary Philips Respironics
09/16/2022ColgateToothpasteDrugsProduct was stored outside of labeled temperature requirementsFamily Dollar
09/16/2022Multiple brand namesVarious OTC medical productsMedical DevicesProduct was stored outside of labeled temperature requirements.Family Dollar
08/20/2020Bayshore Pharmaceuticals, LLCMetformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mgDrugsDue to the Detection of N-Nitrosodimethylamine (NDMA) ImpurityBayshore Pharmaceuticals, LLC
08/18/2020Nuuxsan, Modesa, moreHand SanitizerDrugsUndeclared MethanolALBEK de Mexico S.A. de C.V.
08/20/2020FLORANCE MORRISAntiseptic Hand Sanitizer, 70% AlcoholDrugsPotential Methanol ContaminationGrupo Asimex de Mexico SA de CV
05/03/2019HeritageLosartan Potassium Tablets USPDrugsDue to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)Vivimed
07/19/2019Kogenate®Kogenate® FS antihemophilic factor (recombinant)BiologicsMislabeling-contains the FVIII hemophilia A treatment, Jivi® antihemophilic factorBayerTerminated
06/27/2020SanidermAdvanced Hand SanitizerDrugsMay contain methanol (wood alcohol)Saniderm Products
07/27/2020Resource Recover & Trading, LLCHand SanitizerDrugsUndeclared Methanol subpotency ethyl alcoholResource Recovery & Trading, LLC
07/27/2020Assured, Blumen, ModesaHand SanitizerDrugsUndeclared Methanol4e Brands North America
08/09/2020BersihHand Sanitizer GelDrugsPotential Methanol ContaminationSoluciones Cosmeticas
07/13/2020BlumenHand SanitizerDrugsUndeclared Methanol4e Brands North America
07/25/2019BIOCELL®BIOCELL® textured breast implants and tissue expandersMedical Devices, General & Plastic SurgeryDue to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)Allergan plc
07/19/2021CHANTIXSmoking cessation treatmentDrugsN-Nitroso Varenicline content above ADI levelPfizer
09/16/2021CHANTIXVarenicline tabletsDrugsN-nitroso-varenicline above acceptable daily intake levelPfizer
09/26/2021LillyGlucagon Emergency KitDrugsLoss of potencyEli Lilly and Company
07/20/2020OptimusHand SanitizerDrugsPotential Methanol ContaminationLIQ-E S.A. de C.V.Terminated
04/08/2024Medline and CenturionConvenience kitsMedical DevicesThe potential for a lack of sterilityMedline Industries, LP
07/14/2020bio aaaHand SanitizerDrugsPotential Undeclared Methanol ContaminationAAA Cosmetica, S.A. de C.V.Terminated
07/06/2020All CleanHand sanitizerDrugsPotential presence of methanol (wood alcohol).ITECH 361Terminated
01/23/2024Aligned Medical SolutionsConvenience kits containing salineMedical DevicesProduct cannot be verified as having the required sterility assurance levelAligned Medical Solutions
07/24/2020Shine & CleanHand Sanitizer GelDrugsPotential presence of methanol (wood alcohol)Maquiladora Miniara, S.A. de C.V.Terminated
08/01/2020JalomaHand SanitizerDrugsUndeclared MethanolLaboratorios Jaloma S.A. de C.V.Terminated
07/24/2020Born Basic, Scent Theory and moreHand SanitizerDrugsUndeclared methanolReal Clean Distribuciones SA de CVTerminated
03/25/2021ImperialDietary Supplement for Male EnhancementDrugsUndeclared Sildenafil & TadalafilS&B Shopper LLC
06/15/2021PhilipsPhilips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devicesMedical DevicesPotential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devicesPhilips
09/30/2020CleanerCleaner Hand SanitizerDrugsPotential Presence of Methanol (Wood Alcohol)Estado de México, México, DMM VISSION, S.A. de C.V
01/05/2023Smith’s MedicalCADD Infusion System Infusion Sets for use with CADD pumpsMedical DevicesPotential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.Smith’s Medical
08/18/2020YacanaYacana Hand Sanitizer, 70% AlcoholDrugsPotential Presence of Methanol (Wood Alcohol) and sub-potent ethanolGrupo Yacana México S.A.S de C.V.Terminated
08/25/2020V-Klean, Medical Minded, ProtzHand SanitizerDrugsPotential presence of methanol (wood alcohol) and subpotent ethanol levelsAsiaticon SA de CVTerminated
08/15/2020SkinGuard24All Day Hand SanitizerDrugsContains MethanolSG24 LLCTerminated
06/29/2020SanidermAdvanced Hand Sanitizer, 70% alcohol contentDrugsPotential presence of methanol (wood alcohol)UVT, INC.Terminated
04/22/2022PfizerAccupril (Quinapril HCl) tablets 10mg, 20mg, 40 mgDrugsDue to N-Nitroso-Quinapril ContentPfizerTerminated
05/05/2023PilotCOVID-19 At-Home TestMedical DevicesDue to microbial contamination in the liquid buffer solution.SD Biosensor, Inc.
12/20/2023Busse Hospital DisposalsMedical Device Kits and TraysMedical DevicesDevice & Drug Safety - Potential Lack of SterilityBusse Hospital Disposals
07/10/2024BaxterLife2000 Ventilator with an attached battery charger dongleMedical DevicesPotential Battery Charger Dongle DamageBaxter International, Inc.
08/26/2020Zanilast+Hand sanitizerDrugsProduct contains 1-propanol.Nanomateriales, SA de CVTerminated
08/09/2024BreasVivo 45 LS (US Version) VentilatorMedical DevicesPotential for short term elevated levels of formaldehyde exposureBreas Medical
12/17/2018Envoachem PharmaceuticalsDyural-40 and Dyural-80DrugsDue to Latex HazardAsclemed USA Inc dba Envoachem Pharmeceuticals
03/22/2018BDVacutainer tubesDrugsInaccurate lead test resultsBD
02/01/2019LIFEPAKDefibrillatorMedical Devices, CardiovascularDevice DysfunctionStriker
09/10/2019Metrix, BaxterEmpty IV flexible containers (bag)Medical Devices, General Hospital & Personal UsePotential for leaking of the IV bag at the chamber divider rodThe Metrix Company
01/10/2020LIFEPAK 15LIFEPAK 15 monitor/defibrillatorsMedical DevicesFailure to deliver a defibrillation shock after the “Shock” button on the keypad is pressedStryker
01/08/2020LemonPrep®, PediaPrep®, Wave Prep, Cardio PrepLemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removersMedical DevicesBurkholderia cepaciaMavidon
02/20/2020AbbottCoronary dilatation cathetersMedical DevicesCatheter balloon may not deflate as intendedAbbott
12/07/2023Covidien and Cardinal HealthUrology and OR room specific kits and traysMedical DevicesPotential lack of sterility assurance which could result in non-sterile productCardinal Health
12/21/2022LupinQuinapril 20 and 40 mg tabletsDrugsPresence of nitrosamine impurity, N-Nitroso-QuinaprilLupin Pharmaceuticals Inc.Terminated
12/31/2020GUM ParoexParoex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cupsDrugsPotential contamination with Burkholderia lataPrecision Dose Inc.Terminated
04/19/2021Tenacore LLC2001 Tenacore Replacement CareFusion Alaris 8100 bezelsMedical DevicesPotentially weakened plasticTenacore LLCTerminated
07/28/2020HerbacilHand SanitizerDrugsUndeclared MethanolBroncolin S.A. de C.VTerminated
09/04/2024BivonaBivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)Medical DevicesThe securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.Smiths Medical
09/19/2022Antica FarmacistaOcean Citron Hand SanitizerDrugsProduct contains benzeneSalon Technologies International Inc.Terminated
01/28/2022AuromedicsPolymyxin B for Injection USP, 500,000 Units/VialDrugsPresence of Particulate MatterAuroMedics Pharma LLCTerminated
02/13/2023PrimeZENPrimeZEN Black 6000 male enhancement capsulesDrugsProduct contains undeclared tadalafil and sildenafilVolt CandyTerminated
01/25/2024Zendedidextroamphetamine sulfate tablets, 30 mgDrugsMislabeled packageAzurity Pharmaceuticals, Inc.Terminated
09/18/2024BionPharmaAtovaquone Oral Suspension, 750 mg/mLDrugsProduct found to be contaminated with Cohnella bacteriaBionpharma Inc.
09/23/2024GileadVeklury (remdesivir) for InjectionDrugsDue to Presence of Glass ParticleGilead Sciences, Inc.
10/22/2019Green LumberDietary supplements for male sexual enhancementDrugsContains TadalafilGL HoldingsTerminated
10/07/2024Philips RespironicsTrilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilatorsMedical DevicesThe use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.Philips Respironics, Inc.
10/18/2024MedtronicMiniMed™ 600 series or 700 series insulin pumpsMedical DevicesDevice & Drug Safety - DefectMedtronic plc
10/19/2023MedtronicMcGRATH MAC video laryngoscopesMedical DevicesStolen Potentially DefectiveMedtronic
07/21/2022Multiple brandsMultiple OTC Medical ProductsDrugsProducts stored outside of temperature requirementsFamily Dollar
10/16/2024AK ForteAK Forte Dietary SupplementDrugsDevice & Drug Safety – Unapproved DrugC&A Naturistics
10/16/2024STASKA PharmaceuticalsAscorbic Acid Solution for InjectionDrugsDevice & Drug Safety – Presence of glass particulatesSTASKA Pharmaceuticals Inc.
02/05/2024Covidien and Cardinal HealthExpanded list of Urology and OR room specific kits and traysMedical DevicesPotential lack of sterility assurance which could result in non-sterile productCardinal Health
06/25/2024GlenmarkPotassium Chloride Extended Release 750mg Capsules, 100 count and 500 countDrugsFailed dissolutionGlenmark Pharmaceuticals, Inc.
10/10/2023Multiple brandsOver-the-Counter Drug and Medical Device productsDrugs, Medical DevicesProducts were stored outside of labeled temperature requirementsFamily Dollar
05/04/2023Numerous BrandsVarious human and animal drug productsDrugsAs a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity chaAkorn Operating Company LLC
11/19/2024Par PharmaceuticalClonazepam Orally Disintegrating Tablets, USP (C-IV)DrugsMislabeled with the incorrect strength on the cartonEndo, Inc.
07/17/2024Par PharmaceuticalClonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tabletsDrugsMislabeled with the incorrect strength on the cartonEndo USA, Inc
11/21/2024UmaryUMARY Hyaluronic Acid tabletsDrugsThe product contains undeclared diclofenac and omeprazoleMXBBB
12/20/2023MedlineTracheostomy Care and Cleaning TraysMedical DevicesDevice & Drug Safety - Potential Component DefectMedline Industries, LP
02/27/2024Avanos MedicalMIC* Gastric-Jejunal Feeding Tube KitsMedical DevicesPotential Lack of Sterility AssuranceAvanos Medical, Inc.
12/13/2024Buy-herbal.comNhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsulesDrugsDevice & Drug Safety – Unapproved DrugBuy-herbal.com
12/18/2024FouzeeSugarLin Herbal Formula Herbal Dietary SupplementDrugsProduct contains undeclared Metformin and GlyburideShoppers-Plaza
12/20/2024Par PharmaceuticalAdrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)DrugsProduct is an unapproved drug.Endo, Inc.
12/23/2024SystaneLubricant Eye DrugsDrugsDue to Fungal ContaminationAlcon Laboratories
12/24/2024AstellasTacrolimus and Tacrolimus Extended-Release capsulesDrugsBottles may contain empty capsules.Astellas Pharma US, Inc.