Recalls & alerts

1278 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · August 26, 2026Moderate risk

  Beckman Coulter Inc. : Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU…

  Beckman Coulter DxC 500i Clinical Analyzer Modules and DxC 500 AU Clinical Chemistry Analyzers using software version 1.5 or lower are affected. A software defect can silently overwrite user-customized calculated test rules, potentially generating erroneous patient test results without error notification. The recall is voluntary and firm-initiated.

  devices
• openFDA · August 26, 2026Moderate risk

  Gentherm Medical, LLC : Innercool Coolblue Console, Model STx; Thermal regulating system.

  Gentherm Medical, LLC is recalling its Innercool Coolblue Console, Model STx, a thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down, exposing patients to risk. The recall is voluntary and firm-initiated.

  devices
• openFDA · August 26, 2026Moderate risk

  Fort Defiance Industries, LLC : Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

  Fort Defiance Industries (FDI) is recalling its Automated Field Steam Sterilizer, REF P2131. The water recovery system's 120V Amphenol connector can lose ground continuity, creating an unreliable fault current return path that exposes users to electrical shock. Consumers should stop using the sterilizer and contact Fort Defiance Industries for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Gentherm Medical, LLC : Blanketrol III, Model 233; Thermal regulating system.

  The recall affects the Blanketrol III, Model 233 thermal regulating system made by Gentherm Medical, LLC. Overheating of the 115V CPU board can cause the device to shut down, exposing patients to risk. Consumers should contact Gentherm Medical for instructions.

  devices
• openFDA · August 26, 2026High risk

  Boston Scientific Corporation : Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter

  The recall affects the Boston Scientific ENROUTE Transcarotid Neuroprotection System, material number SR-200-NPS, a percutaneous catheter. The hazard is possible arterial sheath tip separation during use, exposing patients to serious injury. Consumers should stop using the affected device and contact Boston Scientific for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Beckman Coulter Inc. : Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520;…

  Beckman Coulter DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower are affected. A software defect can silently revert user-customized calculated test rules to defaults when importing a new Parameter Package, potentially causing erroneous patient test results. Users should contact Beckman Coulter or follow the recall instructions to correct the issue.

  devices
• openFDA · August 26, 2026High risk

  Bard Access Systems, Inc. : BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver…

  Bard Access Systems, Inc. (BD) is recalling its BD Needle Kit for Powered Driver in 15mm, 25mm, 35mm, 45mm, and 55mm sizes. The obturator may lock to the needle hub, making removal difficult and causing delayed therapy for patients needing intraosseous access. Consumers should stop using the affected kits and contact the firm for return or replacement.

  devices
• openFDA · August 26, 2026Moderate risk

  Medtronic MiniMed, Inc. : MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

  Medtronic MiniMed's MiniMed 640G Insulin Pump models MMT-1711 and MMT-1712 are affected. Loaner pumps cleaned with incompatible products may damage the case or keypad, allow moisture in, and cause over- or under-delivery of insulin, leading to hypoglycemia, hyperglycemia, or diabetic ketoacidosis for users. Consumers should contact Medtronic MiniMed for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Spectral Instruments Inc : Ami HTX

  Spectral Instruments Inc is recalling the Ami HTX device. The device may momentarily fail to show the "X-Ray On" banner during a readiness check, exposing patients and operators to unintended radiation. Consumers must follow the FDA-mandated recall instructions for this device.

  devices
• openFDA · August 26, 2026Moderate risk

  Medtronic MiniMed, Inc. : MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

  The recall affects Medtronic MiniMed 670G Insulin Pump models MMT-1781 and MMT-1782. The hazard is that loaner pumps may have been cleaned with incompatible products, damaging the case or keypad and allowing moisture ingress, which could cause insulin over- or under-delivery and lead to hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Consumers should follow the recall instructions from Medtronic MiniMed.

  devices
• openFDA · August 26, 2026Moderate risk

  Spectral Instruments Inc : Lago X

  Spectral Instruments Inc's Lago X device is affected by this recall. The hazard is a momentary absence of the on-screen X-Ray On banner during a run readiness check, which could expose patients and operators to unintended radiation. Consumers should follow the FDA recall notice for instructions.

  devices
• openFDA · August 26, 2026High risk

  Boston Scientific Corporation : Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

  Boston Scientific's ENROUTE Transcarotid Neuroprotection System Plus, material number SR-250-NPS, a percutaneous catheter, is affected. The hazard is potential arterial sheath tip separation during use, affecting patients worldwide including the US, Australia, Canada, China, and Jamaica. Consumers should contact their healthcare provider or Boston Scientific for instructions on returning the device.

  devices
• openFDA · August 26, 2026Low risk

  Paragon 28, Inc. : Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

  Paragon 28, Inc. recalled its Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, model 6123N R, a foot implant. The implant has elevated oxygen levels above the allowable limit, which may reduce material ductility, exposing patients to potential device failure. Consumers should follow the firm's voluntary recall instructions for this nationwide-distributed product.

  devices
• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics Products Ltd. : Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen (REF L2KSY2(D)/10471981) is affected. The assay may show a negative bias, causing low reactive syphilis results to be reported as nonreactive for patients tested. Consumers should contact their healthcare provider to discuss their results and possible retesting.

  devices
• openFDA · August 26, 2026Moderate risk

  ConvaTec, Inc : Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716,…

  ConvaTec is recalling its Esteem Body Soft Convex Urostomy Pouch models 423703 through 423727. The pouches may leak from the cap during use, affecting patients who use them. Consumers should stop using the affected pouches and contact ConvaTec for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Philips North America Llc : Cardiac Workstation 7000. Product Number: 860441.

  Philips North America is recalling the Cardiac Workstation 7000, product number 860441. The device may intermittently provide inaccurate native heart rate data, affecting patients worldwide. Consumers should contact Philips North America for instructions.

  devices
• openFDA · August 26, 2026High risk

  BMC Medical Co., Ltd. : BMC/REACTHEALTH Luna G3 APAP REF LG 3600

  The recall affects BMC Medical Co., Ltd. and React Health Luna G3 APAP REF LG 3600 devices distributed in Florida. The recall was initiated due to a rework issue at the warehouse, and patients using the device are potentially exposed. Consumers should stop using the device and contact the firm for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Covidien, LLC : EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL…

  Covidien is recalling its EndoFLIP System, including the EF-100 and refurbished RFG-EF100 units and catheter components. The system's 24-hour usage limit incorrectly flags catheters as expired, making them unavailable for clinical procedures, affecting patients and healthcare providers worldwide. Consumers should stop using affected devices and contact Covidien for replacement or further instructions.

  devices
• openFDA · August 26, 2026Low risk

  Paragon 28, Inc. : Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

  Paragon 28, Inc. recalled its Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, model 6123S R, a foot implant. The implant has elevated oxygen levels that may reduce material ductility, posing a risk to patients who received it. Consumers should contact their healthcare provider to determine if they have the affected implant and what steps to take.

  devices
• openFDA · August 26, 2026Moderate risk

  Boston Scientific Corporation : Suture Cinch Long 1pk. Endoscopic tissue approximation device.

  Boston Scientific is recalling its Suture Cinch Long 1pk endoscopic tissue approximation device. The device may fail to deploy the cinch implant or cut the suture, posing a risk to patients undergoing endoscopic procedures. Consumers should stop using the affected device and contact Boston Scientific for further instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics Products Ltd. : Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen is affected. The assay may report low reactive syphilis results as nonreactive, exposing patients to false negative results. Consumers should contact their healthcare provider to discuss whether retesting is necessary.

  devices
• openFDA · August 26, 2026Moderate risk

  Philips North America Llc : Cardiac Workstation 5000. Product Number: 860439.

  Philips North America LLC is recalling the Cardiac Workstation 5000, product number 860439. The device may intermittently provide inaccurate native heart rate data, affecting patients and users worldwide. Consumers should contact Philips North America for further instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Medtronic MiniMed, Inc. : MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

  The affected product is the Medtronic MiniMed 780G Insulin Pump, models MMT-1885CLW and MMT-1886CLW. Users of these loaner pumps may face incorrect insulin delivery due to chemical damage from cleaning, risking hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Consumers should contact Medtronic MiniMed for instructions on returning or replacing the affected pump.

  devices
• openFDA · August 26, 2026Moderate risk

  American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number…

  American Contract Systems is recalling medical procedure kits and trays, including Crani Pack, Spine Pack, and others, distributed in Minnesota, Missouri, and Iowa. The kits contain Ritmed Neurological Sponges with potentially variable endotoxin levels, posing a risk to patients undergoing procedures. Consumers should check the recall notice for affected model numbers and contact American Contract Systems for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Foundation Medicine, Inc. : Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

  Foundation Medicine's Hamilton Microlab STAR Liquid Handler with Protocol Configuration Tool v2.0.0 is recalled. The software issue increases spontaneous software closures, which can affect patients whose diagnostic tests are run on this system. Users should stop using the affected software and contact Foundation Medicine for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Kico Knee Innovation Company : Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap…

  The recalled product is the Kico Knee Innovation ARVIS Surgical Navigation System Gen 2, model IN-29200. An internal sensor issue can make the eyepiece image appear tilted, exposing surgeons and patients to incorrect navigation during orthopedic surgery. Users should stop using the affected system and contact Kico Knee Innovation for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Tobii Dynavox Llc : TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

  Tobii Dynavox LLC is recalling the TD Navio Midi Speech Generating Device, model 1000798. Damaged battery mounting tabs can let the battery move, causing an internal short circuit, localized heating, and gas venting, affecting users nationwide. The recall is voluntary and firm-initiated.

  devices
• openFDA · August 26, 2026Moderate risk

  Paragonix Technologies Inc. : Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

  Paragonix Technologies Inc. is recalling its KidneyVault Portable Renal Perfusion System, REF# PRGNX-8008-001. A firmware defect can cause the datalogger to lose configuration, resulting in a blank screen and loss of displayed preservation parameters, putting the transported

  devices
• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics, Inc. : Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

  Siemens Healthcare Diagnostics is recalling its Syva EMIT 2000 Quinidine Assay, REF 4Q019UL. The assay may produce falsely high quinidine measurements, which can lead to sub-optimal treatment, including life-threatening cardiac arrhythmias or inadequate antimalarial therapy for patients. Consumers should follow the instructions from Siemens Healthcare Diagnostics regarding this voluntary recall.

  devices
• openFDA · August 26, 2026Moderate risk

  restor3d Inc. : Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software…

  The recall affects restor3d Veritas Standard Reverse Total Shoulder glenoid baseplate models 1500-1030 and 1500-1035. The baseplate has incorrectly machined screw holes, which may cause peripheral screws to engage improperly, exposing patients to potential implant failure. Patients should contact their surgeon or restor3d for instructions on returning or replacing the affected device.

  devices
• openFDA · August 26, 2026Moderate risk

  Gentherm Medical, LLC : Blanketrol II Model 222S; Thermal regulating system.

  Gentherm Medical, LLC is recalling its Blanketrol II Model 222S thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down, affecting patients worldwide. The recall is voluntary and firm-initiated, with no consumer action specified.

  devices
• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics, Inc. : Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

  The Beckman Coulter Emit 2000 Quinidine Assay REF OSR4Q229 is affected. The hazard is unacceptable precision performance causing erroneously elevated quinidine measurements, risking life-threatening cardiac arrhythmias or inadequate antimalarial therapy for patients. The recall notice does not specify a consumer action; it is a voluntary firm-initiated recall.

  devices
• openFDA · August 26, 2026Moderate risk

  American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…

  American Contract Systems is recalling its Anterior Cervical Pack (model MHAC65AH) and Spine Pack (model MHSP99AF) medical procedure kits and trays. The kits contain Ritmed Neurological Sponges that may have unexpected endotoxin levels, posing a risk to patients during surgery. Consumers should stop using the recalled kits and contact American Contract Systems for return or replacement.

  devices
• openFDA · August 26, 2026Moderate risk

  Intersurgical Inc : One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

  The recall affects Intersurgical Inc's One-Piece Guedel Airway, size 00, ISO 5.0, Blue, an oropharyngeal airway device. The device could be occluded or partially occluded, posing a risk to patients who use it. Consumers should stop using the recalled airway and contact Intersurgical for instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  AVID Medical, Inc. : Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

  AVID Medical, Inc. is recalling the Halyard LAVH PACK, model USAR053-11, which contains the Clearify Visualization System. The component was sterilized with ethylene oxide against manufacturer guidance, which may cause it to leak, exposing patients to risk. Consumers should stop using the affected kits and contact AVID Medical for return instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Boston Scientific Corporation : OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

  Boston Scientific is recalling its OverStitch Suture Cinch, a single-pack endoscopic tissue approximation device. The device may fail to deploy the cinch implant or cut the suture, posing a risk to patients undergoing the procedure. Consumers and healthcare providers should stop using the affected devices and contact Boston Scientific for return and replacement instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  Intersurgical Inc : One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

  Intersurgical Inc's One-Piece Guedel Airway, size 000, ISO 3.5, Light Green oropharyngeal airway device is recalled. The device could be occluded or partially occluded, posing a risk to patients who use it. Consumers should stop using the recalled device and contact Intersurgical for return or replacement instructions.

  devices
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx…

  American Regent, Inc. is recalling Tralement (trace elements injection 4*, USP) in 1mL and 5x1mL single dose vials. The vials may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC…

  American Regent, Inc. is recalling Cyanocobalamin injection USP, 1,000 mcg/mL, in 1 mL multi-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients who receive the injection. Consumers should stop using the recalled vials and contact their healthcare provider or the company for instructions.

  drugs
• openFDA · August 26, 2026Moderate risk

  SUN PHARMACEUTICAL INDUSTRIES INC : Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed…

  Taro Carbamazepine Tablets, USP, 200mg, in 1000-count bottles, are affected. The tablets may contain black spots from burnt excipient, posing a risk to patients taking them. Consumers should stop using the affected tablets and return them to their pharmacy.

  drugs
• openFDA · August 26, 2026High risk

  Fresenius Kabi USA, LLC : Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake…

  Fresenius Kabi is recalling Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes. The syringe labeled as morphine may actually contain Dilaudid, exposing patients to a different, more potent opioid. Consumers should stop using the recalled syringes and return them to their pharmacy or healthcare provider.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose…

  American Regent, Inc. is recalling Selenious Acid Injection, USP 12 mcg/2 mL, a prescription drug for intravenous use. The product may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for instructions.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE…

  American Regent, Inc. is recalling Aminocaproic Acid Injection, USP, 250 mg/mL in 20 mL multiple dose vials. The vials may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients receiving IV infusion. Consumers should stop using the recalled vials, return them to the pharmacy, and contact their healthcare provider for guidance.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials…

  American Regent, Inc. is recalling niCARdipine Hydrochloride Injection, USP, 25 mg/10mL, in single-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients receiving the injection. Consumers should stop using the recalled vials and contact their pharmacist or American Regent for instructions.

  drugs
• openFDA · August 26, 2026Moderate risk

  Shilpa Medicare Limited : PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India;…

  PEMRYDI RTU (pemetrexed injection) 500 mg/50 mL single-dose vials, distributed by Amneal Pharmaceuticals, are affected. The vials may contain a green to dark green discolored solution, posing a risk to patients receiving this prescription injection. Consumers should not use the recalled vials and should contact their healthcare provider or pharmacy.

  drugs
• openFDA · August 26, 2026Moderate risk

  Mylan Pharmaceuticals Inc : Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc.,…

  Mylan Pharmaceuticals Inc. is recalling Acamprosate Calcium Delayed-Release Tablets, 333 mg, in 180-tablet bottles. The tablets fail dissolution specifications, which may affect patients taking this prescription medication. Consumers should contact their pharmacist or healthcare provider for guidance.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN…

  American Regent, Inc. is recalling nitroglycerin injection, USP, 50 mg/10 mL, in 10 mL vials. The product contains particulate matter such as hair, glass, and paraformaldehyde, posing a safety risk to patients who receive the injection. Consumers should stop using the recalled vials and contact their healthcare provider or pharmacy for instructions on returning the product.

  drugs
• openFDA · August 26, 2026Moderate risk

  Regeneron Pharmaceuticals Inc : Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron…

  Regeneron Pharmaceuticals is recalling Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL, a prescription drug for intravenous infusion. The product may lack assurance of sterility, posing a risk of infection to patients who receive it. Patients should stop using the recalled product and contact their doctor or pharmacist for guidance.

  drugs
• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose…

  American Regent, Inc. is recalling Atropine Sulfate injection, USP, 1 mg/mL, in single-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients given the drug intravenously. Consumers should stop using the recalled vials and follow the company's recall instructions.

  drugs
• openFDA · August 26, 2026Moderate risk

  Shilpa Medicare Limited : PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India;…

  The recall affects PEMRYDI RTU (pemetrexed injection) 100 mg/10 mL single-dose vials, distributed by Amneal Pharmaceuticals. Certain vials contain a green to dark green discolored solution, posing a risk to patients who receive this injectable drug. Consumers should stop using the affected vials and contact their healthcare provider or pharmacy for replacement and guidance.

  drugs

Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.