Drug Recalls Center

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

514
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

Getinge Recalls VASOVIEW HEMOPRO 3 Vessel Harvesting System

Getinge recalled 98 units of the VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting System on August 5, 2025. The recall addresses out-of-box failures including malfunctioning jaws and heater wires. No serious injuries were reported related to these failures.

Maquet Cardiovascular
On August
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HIGHFDA FOOD

Hi-Tech Pharmaceuticals Recall Dietary Supplement Over Misbranding

Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol on August 6, 2025 due to unapproved drug claims. The product supports cardiovascular health but lacks proper approval. Consumers should stop using the supplement immediately and contact the company for a refund.

Hi-Tech Pharmaceuticals
Unapproved Drug
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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 DRUG

Haleon US Holdings Recalls Sensodyne Toothpaste Due to Label Mix-Up

Haleon US Holdings recalled 46,692 tubes of Sensodyne PRONAMEL toothpaste on August 5, 2025, due to a labeling mix-up. The outer carton states Fresh Mint while the tube claims Cool Mint/Whitening. The actual product inside is Fresh Mint, leading to potential consumer confusion.

Haleon US Holdings
Labeling: Label
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HIGHFDA DRUG

Sandoz Recalls Enoxaparin Sodium Injection Due to Mislabeling

Sandoz Inc. recalled 10 bags of Enoxaparin Sodium Injection on August 5, 2025. Bags labeled for Enoxaparin Sodium 80 mg/0.8 mL contained the incorrect dosage of 30 mg/0.3 mL. Consumers and healthcare providers must stop using the product immediately.

ENOXAPARIN SODIUM
Correct Labeled
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HIGHFDA DEVICE

Boston Scientific NephroMax Kit Recalled Over Foreign Material Risk

Boston Scientific recalled 458 NephroMax Kits on August 5, 2025, due to contamination risk. The Encore 26 Inflation Device may allow foreign particles to enter balloon dilatation catheters. Patients must stop using the device immediately and follow recall instructions.

Boston Scientific
The Encore
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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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HIGHFDA DEVICE

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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HIGHFDA DEVICE

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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HIGHFDA DEVICE

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

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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