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

Waldemar Link Recalls Knee Fusion Nail Due to Assembly Error

Waldemar Link GmbH & Co. KG recalled 18 units of the Endo Model Knee Fusion Nail SK on November 10, 2025. The device features a preassembled locking screw incorrectly inserted, posing a high risk of failure. Affected units were distributed in Alabama, Georgia, and Texas.

Waldemar Link GmbH & Co. KG
The device
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HIGHFDA DEVICE

Draeger Recalls Airway Connector Over Cracking Hazard

Draeger recalled 118,850 airway connectors on November 10, 2025, due to cracking hazards. This recall affects multiple countries, including the United States and Australia. The device poses a serious risk to mechanically ventilated patients.

Draeger
Multiple complaints
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HIGHFDA DRUG

Actavis Recalls Testosterone Gel Due to Leakage Risk

Actavis Laboratories recalled 15,944 cartons of Testosterone Gel on November 7, 2025. The recall follows a defect in the side-seal of the containers, which may allow product leakage. Consumers must stop using the product immediately and contact their healthcare providers for guidance.

TESTOSTERONE
Defective Container
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HIGHFDA DEVICE

C.R. Bard Ureteral Stent Kit Recalled Due to Labeling Discrepancy

C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual stent size to differ from the labeled size. Healthcare providers and patients should stop using the device immediately.

C.R. Bard
Labeling discrepancy;
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HIGHFDA DEVICE

C.R. Bard Recalls Ureteral Stent Kit Due to Labeling Discrepancy

C.R. Bard Inc recalled 116 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall stems from a labeling discrepancy where the actual stent size may not match the product label. This recall affects distribution in multiple U.S. states and several countries worldwide.

C.R. Bard
Labeling discrepancy;
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HIGHFDA DEVICE

Bard Peripheral Vascular Catheter Drainage Tray Recalled Due to Hazard

Bard Peripheral Vascular recalled 1,240 Safe-T-Centesis Catheter Drainage Trays due to safety indicator defects. The recall affects products distributed nationwide since November 6, 2025. The defect may cause serious injuries during use in medical procedures.

Bard Peripheral Vascular
Acute drainage
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HIGHFDA DEVICE

C.R. Bard Ureteral Stent Kit Recalled Due to Labeling Discrepancy

C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual size of the stent to differ from what is indicated on the label. The recall affects distribution across the U.S. and several countries worldwide.

C.R. Bard
Labeling discrepancy;
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HIGHFDA DEVICE

C.R. Bard Recalls Ureteral Stent Kit Due to Labeling Discrepancy

C.R. Bard recalled 4,350 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall was initiated due to a labeling discrepancy where the actual size of the stent may not match its label. This affects distribution across the U.S. and several countries worldwide.

C.R. Bard
Labeling discrepancy;
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HIGHFDA DEVICE

Cepheid Recalls Xpert MTB/RIF Test Due to Stability Issues

Cepheid recalled 9,880 units of the Xpert MTB/RIF testing device on November 5, 2025. Product testing failed to meet expected stability criteria, leading to potential inaccuracies. Healthcare providers and patients must stop using the device immediately.

Cepheid
Product testing
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HIGHFDA DEVICE

Diasol Recalls Liquid Concentrate for Dialysis Due to Safety Concerns

Diasol recalled 74,400 gallons of its Liquid Concentrate for Bicarbonate Dialysis on November 5, 2025. The recall stems from concerns about the safety and efficacy of the dialysis acid concentrate. Patients and healthcare providers should stop using the product immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 186,000 containers of its liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately and follow recall instructions.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.

Diasol
Safety and
Read more
HIGHFDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Over Maintenance Issues

Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.

Datascope
The IFU
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Organic Acids Test

GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Medical Device Recalled for Illegal Marketing

GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.

GET TESTED INTERNATIONAL AB
Distribution without
Read more

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