Drug Recalls Center

1,425 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,425
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

REPLIGEN Spectrometer Recalled Due to Laser Hazard

REPLIGEN Corporation recalled 33 Maverick Measurement Module Spectrometers on December 10, 2025. Disconnected or poorly crimped cables may cause elevated laser output or unintended firing. The recall affects devices distributed in the U.S.

REPLIGEN
Potential Elevated
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Due to Fall Risk

GE HealthCare recalled 12 Nuclear Medicine systems on December 10, 2025, due to a potential fall hazard. The affected systems may have inadequate support during transport, risking detector integrity. No injuries have been reported, but the risk of life-threatening incidents exists.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Elekta Recalls MOSAIQ Oncology System Over Overtreatment Risk

Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.

Elekta
Using oncology
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HIGHFDA DEVICE

GE Healthcare Recalls Nuclear Medicine Systems Due to Fall Hazard

GE Healthcare recalled seven Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The recall affects systems that have exceeded their End of Guaranteed Service. No injuries or falls have been reported.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Mazor Robotics Recalls Robotic Guidance System Over Software Errors

Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.

Mazor Robotics
Software errors
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HIGHFDA DEVICE

Heraeus Medical Recalls PALACOS Bone Cement Due to Breakage Risk

Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.

Heraeus Medical GmbH
increase of
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HIGHFDA DEVICE

IMRIS Imaging Recalls Head Fixation Device Over Safety Concerns

IMRIS Imaging recalled 122 Head Fixation Devices on December 8, 2025. A torque screw may crack or separate, posing serious risks during surgical procedures. Healthcare providers must stop using the device and follow recall instructions immediately.

IMRIS Imaging
Torque screw
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HIGHFDA DRUG

ORL Kids Toothpaste Recalled Due to cGMP Deviations

ORL Labs recalled 1,458 containers of ORL Kids Natural Toothpaste, Bubblegum Flavor, on December 8, 2025. The recall follows cGMP deviations that could pose health risks. Consumers should stop using the product immediately.

ORL Labs
cGMP Deviations
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HIGHFDA DEVICE

Beckman Coulter Recalls LDL Cholesterol Assay Due to Performance Issues

Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.

Beckman Coulter Ireland
Beckman Coulter
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HIGHFDA DRUG

ORL Labs Recalls Kids Mouthwash Over cGMP Deviations

ORL Labs, LLC recalled 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor on December 8, 2025. The recall stems from violations of current Good Manufacturing Practices (cGMP). The product was distributed only in Arizona and poses potential safety risks for children.

ORL Labs
cGMP Deviations
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HIGHFDA DEVICE

Philips Azurion Systems Recalled Due to Software Issues

Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nine (9)
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HIGHFDA DEVICE

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Beaver-Visitec International
Manufacturing deviation
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HIGHFDA DEVICE

Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk

Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.

Siemens Medical Solutions USA
A potential
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HIGHFDA DEVICE

LimFlow Vector Medical Device Recalled Due to Expiration Date Error

LimFlow recalled 33 units of its Vector model VT-US-23 on December 5, 2025, due to incorrect expiration dates. Patients and healthcare providers should stop using this device immediately. The recall affects distribution across 14 states and the District of Columbia.

LimFlow
Incorrect expiration
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HIGHFDA DEVICE

Abiomed Recalls Impella 5.5 Devices Due to Packaging Error

Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.

Abiomed
Device packaged
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HIGHFDA DEVICE

Mobius Imaging Recalls AIRO CT X-ray Pendant Over Safety Label Issue

Mobius Imaging recalled 101 units of the AIRO Computed Tomography X-ray system pendant on December 4, 2025. The pendants lack a critical "Safe Hand Position Warning" label, posing a safety risk for healthcare providers. Users should immediately stop using these devices and follow recall instructions.

Mobius Imaging
AIRO pendant
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HIGHFDA DEVICE

Merit Medical Recalls Inflation Device Due to Detachment Hazard

Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Recalls Custom Manifold Kit Due to Detachment Risk

Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.

Merit Medical Systems
Inflation device
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