Drug Recalls Center

1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,355
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

Medline Recalls Medical Kits Due to Seal Integrity Issues

Medline Industries, LP recalled 7,570 medical convenience kits on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks with an open seal risk. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Intubation Tray Over High Hypoxia Risk

Medline Industries, LP recalled 130 Intubation Trays on December 24, 2025. The recalled trays may contain a smaller suction catheter that could cause respiratory failure. Patients and healthcare providers should stop using the device immediately.

Medline Industries, LP
A smaller
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HIGHFDA DEVICE

Medline Recalls Suture Removal Trays Due to Seal Failure

Medline Industries, LP recalled 2,448 Suture Removal Trays on December 24, 2025. The recall affects kits containing BD ChloraPrep Triple Swabsticks with potentially open seals. The company urges immediate cessation of use to avoid potential hazards.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Pediatric Catheter Kits Over Seal Issues

Medline Industries, LP recalled 450 pediatric catheter securement kits on December 24, 2025. The kits may contain BD ChloraPrep Triple Swabsticks with potential open seals. Users should stop using the products immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Seal Defect Risk

Medline Industries, LP recalled 8,445 medical convenience kits on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks which may have an open seal. This defect poses a high risk to patients and healthcare providers.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Sterile Resection Kits Due to Open Seal Hazard

Medline Industries, LP announced a recall of 216 kits packaged as Sterile Resection Packs on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks that may have an open seal. The recall affects healthcare providers and patients nationwide.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Open Seal Hazard

Medline Industries, LP recalled 168 medical convenience kits on December 24, 2025. The kits may contain BD ChloraPrep Triple Swabsticks with open seals. This recall affects products distributed nationwide in the U.S.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Focalyx Technologies Recalls Software Device Over Patient Safety Risks

Focalyx Technologies issued a recall for its Focalyx Fusion software device on December 23, 2025. The device may malfunction with Windows 10, potentially causing patient harm during prostate biopsies. Users must stop using the device immediately until it is validated with Windows 11.

Focalyx Technologies
Software device
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HIGHFDA DEVICE

Beckman Coulter Sample Preparation System Recalled for Software Error

Beckman Coulter recalled 50 units of the CellMek SPS Sample Preparation System on December 23, 2025. A software error causes sample dispensation issues leading to potential sample loss and incorrect diagnoses. Healthcare providers should stop using the device immediately.

Beckman Coulter
Sample preparation
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HIGHFDA DRUG

HANDELNINE GLOBAL Recalls Rheumacare Capsules Due to Lead Risk

HANDELNINE GLOBAL recalled Rheumacare capsules on December 22, 2025, after discovering lead contamination. The recall affects four bottles of 30 capsules each distributed in New York. Consumers should stop using the product immediately and contact their healthcare provider.

HANDELNINE GLOBAL
CGMP Deviations:
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HIGHFDA DRUG

Baxter Healthcare Recalls Sterile Water for Irrigation Over Contamination

Baxter Healthcare Corporation recalled 125,496 bottles of Sterile Water for Irrigation on December 22, 2025. Plastic particles from the bottle rim contaminated the solution, posing a health risk. Consumers and healthcare providers must stop using the product immediately and seek guidance.

STERILE WATER
Presence of
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HIGHFDA DEVICE

Medline Catheters Recalled Over Infection Risk

Medline Industries recalled 228 lots of ReNewal Reprocessed Webster CS Catheters on December 22, 2025. These catheters may contain small particles that pose serious health risks, including systemic infection. Patients must stop using them immediately and follow the recall instructions.

Medline Industries, LP
These lots
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HIGHFDA DEVICE

Medline Industries Recalls Ultrasound Catheters Over Infection Risk

Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.

Medline Industries, LP
These lots
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HIGHFDA DEVICE

Medline Industries Issues Recall of Catheters Over Infection Risk

Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.

Medline Industries, LP
These lots
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HIGHFDA DEVICE

Medline ReNewal Catheters Recalled Due to Infection Risk

Medline Industries, LP recalled 650 ViewFlex Xtra ICE Catheters on December 22, 2025. The recall affects devices that may contain small particles of residual material. Using these catheters poses a risk of serious health complications such as systemic infection or embolism.

Medline Industries, LP
These lots
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HIGHFDA DEVICE

Medline Electrophysiology Catheters Recalled Over Infection Risk

Medline Industries recalled 41 lots of reprocessed electrophysiology catheters on December 22, 2025. These devices may contain residual material that poses serious health risks. The recall affects several specific model numbers and follows the expansion of a previous recall.

Medline Industries, LP
These lots
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HIGHFDA DEVICE

Abbott Catheters Recalled Over Risk of Infection and Embolism

Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.

Medline Industries, LP
These lots
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HIGHFDA DRUG

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
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