Drug Recalls Center

895 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

895
Total Drug Recalls
24
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

HIGHFDA DEVICE

Philips Medical Systems Recalls Radiation Therapy Planning Software

Philips Medical Systems recalled 810 units of its Radiation Therapy Planning System on August 5, 2025. A software issue may cause image errors during treatment planning. Affected models include Pinnacle TumorLOC and Multimodality Simulation Workspace.

Philips Medical Systems
Due to
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HIGHFDA DEVICE

Tandem Diabetes Care Insulin Pumps Recalled Over Hypoglycemia Risk

Tandem Diabetes Care recalled 122,958 insulin pumps on August 5, 2025. A software defect may cause unexpected insulin boluses, leading to hypoglycemia. Patients should stop using the devices immediately and follow the manufacturer's instructions.

Tandem Diabetes Care
A software
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HIGHFDA DEVICE

AVID Medical Recalls Convenience Kit Over Sterility Risk

AVID Medical recalled 57 units of the Halyard ENT Pack on August 4, 2025. The recall stems from potential open header bag seals that may compromise sterility. Patients and healthcare providers must stop using this device immediately.

AVID Medical
Potential for
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HIGHFDA DEVICE

Beckman Coulter Recalls DxC 500i Analyzer Modules Over Processing Delays

Beckman Coulter recalled 116 DxC 500i Clinical Analyzer modules on August 4, 2025, due to potential processing delays. The defect may impact the accuracy of test results when ordering certain tests simultaneously. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Beckman Coulter
On a
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Waldemar Link Recalls LinkSymphoKnee Tibial Component Over Safety Hazard

Waldemar Link GmbH & Co. KG recalled eight units of the LinkSymphoKnee Tibial Component on July 31, 2025. The recall stems from a manufacturing error involving uncoated security screws. Patients and healthcare providers should stop using the device immediately.

Waldemar Link GmbH & Co. KG
Some modular
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Medline Recalls ViewFlex Xtra ICE Catheters Over Infection Risk

Medline Industries recalled 7,913 reprocessed ViewFlex Xtra ICE catheters on July 31, 2025. The recall affects specific lots due to potential residual particulates that may cause serious health risks. Patients and healthcare providers must stop using the devices immediately.

Medline Industries, LP
Specific lots
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Medline Recalls Ultrasound Catheters Over Infection Risk

Medline Industries recalled 7,913 reprocessed AcuNav Ultrasound Catheters on July 31, 2025. The devices may contain harmful residual particulates that pose an infection risk. Patients and healthcare providers should stop using these devices immediately and follow recall instructions.

Medline Industries, LP
Specific lots
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Medline Recalls Catheters Due to Infection Risk from Particulates

Medline Industries recalled 7,913 electrophysiology catheters on July 31, 2025, due to contamination concerns. Specific lots may contain small residual particulates, posing risks of systemic infection and thrombus formation. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Specific lots
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Medline Industries Recalls Electrophysiology Catheters Over Infection Risk

Medline Industries recalled 7,913 reprocessed electrophysiology catheters on July 31, 2025. Residual particulates on patient-contacting surfaces pose a risk of serious infection and thrombus formation. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Specific lots
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HIGHFDA DEVICE

Fortress Introducer Sheath System Recalled Due to Labeling Error

Contract Medical International GmbH recalled 2,500 Fortress Introducer Sheath Systems on July 30, 2025. Units may have incorrect pouch labeling, leading to potential use of the wrong device version. Patients and healthcare providers should stop using the product immediately.

Contract Medical International GmbH
Units may
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HIGHFDA DRUG

Exela Pharma Recalls Sodium Bicarbonate Injection Over Arsenic Risk

Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.

SODIUM BICARBONATE
Failed Impurities/Degradation
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S.I.N. Implant System Recalls Dental Implants Over Quality Concerns

S.I.N. Implant System Ltda recalled 4,367 dental implants on July 30, 2025, due to improper storage conditions. The recalled products may have compromised packaging, affecting their quality and performance. Patients and healthcare providers should stop using these devices immediately.

S.I.N. Implant System Ltda
Dental implants
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Due to Calibration Failures

Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Over Calibration Failures

Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.

Ortho-Clinical Diagnostics
VITROS Chemistry
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