Drug Recalls Center

1,894 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,894
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.

Health & Personal Care
HIGH
FDA DRUG

DPT Laboratories Recalls Diclofenac Sodium Gel Over PH Specification Failure

DPT Laboratories recalled 92,376 tubes of Diclofenac Sodium Topical Gel, 1%, on December 22, 2025. The recall is due to the product failing pH specifications, posing a high risk to consumers. Users should stop using the gel immediately and contact healthcare providers for guidance.

DICLOFENAC SODIUM
Failed PH
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Issues Recall for Patient Information Center Software

Philips North America recalled 146 units of Patient Information Center software on December 22, 2025. A software patch modifies Mobile Event Notification filter settings without notifying users. The recall affects units distributed worldwide, including 41 in the U.S.

Philips North America
A recent
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls St. Jude Electrophysiology Catheters Over Infection Risk

Medline Industries recalled reprocessed St. Jude electrophysiology catheters on December 22, 2025. The recall affects 48 units potentially contaminated with residual materials. The defective catheters pose a high risk of inflammation and systemic infection.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Tornier Recalls Surgical Screws Over Labeling Error

Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.

Tornier
A specific
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Altruan GmbH Bisaf Strep A Self-Test Recalled for FDA Clearance Issue

Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.

Altruan
Product not
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Over Deployment Issues

Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

Tyber Medical recalled 64 units of the VOLT Wrist Treatment System on December 19, 2025. The recall affects model number 02.426.691S due to incorrect thread orientation in anatomical left plates. Patients and healthcare providers should stop using this device immediately.

Tyber Medical
The supplier
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Stent Recalled Over Deployment Issues

Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.

Tyber Medical
The supplier
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

MicroPort Recalls HIPTURN Fem Head Trial Device Over FDA Violation

MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.

MicroPort Orthopedics
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Needles Free Access Devices Due to High Risk of Leakage

ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.

ICU Medical
Needle free
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.

ICU Medical
Affected lots
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