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

Baxter Healthcare Recalls IV Extension Sets Due to Leakage Risk

Baxter Healthcare recalled 2,304 Clearlink System Extension Sets on August 29, 2025, due to potential leakage. The recall affects IV sets distributed nationwide across multiple states. Healthcare providers and patients should stop using the device immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheters Over Sterility Risk

Northeast Scientific recalled 173 units of the R-414-151 laser atherectomy catheter on August 29, 2025. The recall stems from potential breaches in the sterile packaging, which could compromise sterility assurance. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 18,720 IV solution sets on August 29, 2025, due to a leak hazard. The recall affects devices distributed across the United States, including all 50 states. Patients and healthcare providers should stop using these devices immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 12,720 CONTINU-FLO Solution Sets on August 29, 2025, due to a risk of leakage. The recall affects various states across the U.S. Healthcare providers and patients must stop using the product immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 141 units of the 2.0mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall stems from potential breaches in the sterile barrier packaging, risking patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leak Risk

Baxter Healthcare recalled 136,512 IV sets on August 29, 2025, due to potential leaks. The recall affects products distributed nationwide across the United States. Patients and healthcare providers must stop using these devices immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leakage Risk

Baxter Healthcare recalled 473,040 IV solution sets on August 29, 2025, due to a leak hazard. The affected product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Product Code 2C8519. Healthcare providers and patients must stop using this device immediately and follow recall instructions.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 1,167,120 units of its CLEARLINK SYSTEM CONTINU-FLO Solution Set on August 29, 2025. The recall affects IV sets due to a risk of leakage that could pose serious health risks. Patients and healthcare providers should stop using these devices immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

ImaCor Recalls Miniaturized TEE Probe Due to Assembly Error

ImaCor recalled 45 units of the ClariTEE Miniaturized TEE probe on August 29, 2025, due to a production assembly error. The defect may cause the probe to articulate incorrectly, posing a risk to patient safety. Healthcare providers and patients must stop using the device immediately.

ImaCor
Production assembly
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HIGHFDA DEVICE

Getinge Recalls 88-Series Washer-Disinfector Due to Overheating Risk

Getinge recalled 788 units of its 88-Series Washer-Disinfector on August 29, 2025. The device may overheat if the circulation pressure calibration is incorrect and the low-pressure alarm fails. This recall affects devices distributed worldwide, including several U.S. states.

Getinge Disinfection Ab
Potential for
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HIGHFDA DRUG

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Contamination Risk

Granules Pharmaceuticals Inc. recalled 9,917 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The product failed impurities and degradation specifications, posing potential health risks. Consumers should stop using the capsules immediately and consult healthcare providers for guidance.

Granules Pharmaceuticals
Failed Impurities/Degradation
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HIGHFDA DRUG

Granules Pharmaceuticals Recalls Amphetamine Capsules Over Impurity Risks

Granules Pharmaceuticals recalled 11,928 bottles of amphetamine capsules on August 28, 2025. The recall follows failure to meet impurities and degradation specifications. Consumers should stop using the product immediately and contact their healthcare providers.

Granules Pharmaceuticals
Failed Impurities/Degradation
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HIGHFDA DRUG

Ascend Laboratories Recalls Aripiprazole Tablets Due to Potency Risk

Ascend Laboratories, LLC recalled 2,256 bottles of Aripiprazole Tablets on August 28, 2025. The recall followed reports that the drug may be superpotent, posing serious health risks. Consumers should stop using the product immediately and consult healthcare providers.

ARIPIPRAZOLE
Superpotent drug
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HIGHFDA DRUG

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Impurity Concerns

Granules Pharmaceuticals Inc. recalled 11,909 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The recall stems from failure to meet impurities and degradation specifications. Healthcare providers and consumers must stop using the product immediately.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Failed Impurities/Degradation
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HIGHFDA DRUG

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules for Impurities

Granules Pharmaceuticals Inc. recalled 11,895 bottles of extended-release capsules on August 28, 2025. The capsules failed impurities and degradation specifications. Consumers should stop using the product immediately, as it could pose health risks.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Failed Impurities/Degradation
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HIGHFDA DRUG

Granules Pharmaceuticals Recalls Amphetamine Capsules for Degradation Issues

Granules Pharmaceuticals Inc. recalled 3,384 bottles of amphetamine capsules on August 28, 2025. The recall follows a failure to meet impurities and degradation specifications. Consumers should stop using this product immediately and consult healthcare providers.

Granules Pharmaceuticals Inc.
Failed Impurities/Degradation
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HIGHFDA DEVICE

Siemens MRI Scanner Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 39 MAGNETOM Prisma MRI scanners on August 28, 2025, due to a potential helium leak hazard. The recall affects units distributed worldwide, with a significant risk of helium gas build-up within the containment system. Healthcare providers must stop using the device immediately and follow recall instructions.

Siemens Medical Solutions USA
There is
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HIGHFDA DEVICE

Siemens Medical MRI Scanner Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled the MAGNETOM Connectom.X. MRI Scanner on August 28, 2025. The recall affects one unit worldwide due to a potential helium leak risk. Users must stop using the device immediately as it poses a high hazard level.

Siemens Medical Solutions USA
There is
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HIGHFDA DEVICE

Siemens MRI Device Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 27 units of its MAGNETOM Vida Fit MRI system on August 28, 2025. The recall addresses a risk of ice blockage that can cause helium gas pressure build-up. This defect may lead to a helium leak in the scanning room, posing a safety hazard.

Siemens Medical Solutions USA
There is
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HIGHFDA DEVICE

Siemens MRI Scanner Recalled Due to High Pressure Risk

Siemens Medical Solutions USA recalled nine MRI scanners on August 28, 2025. The devices may develop ice blockages in the venting system, risking helium leaks. Healthcare providers must stop using the scanners immediately.

Siemens Medical Solutions USA
There is
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HIGHFDA DEVICE

Siemens Recalls Biograph mMR Due to High Pressure Risk

Siemens Medical Solutions USA recalled 23 units of the Biograph mMR on August 28, 2025, due to a potential helium leak risk. The recall affects devices distributed worldwide, including the US. This Class I recall poses a high hazard to patients and healthcare providers.

Siemens Medical Solutions USA
There is
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HIGHFDA DEVICE

Siemens Medical Recalls MRI Machine Over Helium Leak Risk

Siemens Medical Solutions USA recalled 182 MRI machines on August 28, 2025, due to a risk of helium leaks. An ice blockage in the magnet venting system could cause pressure build-up, leading to a potential rupture. Users must stop using the device and follow recall instructions immediately.

Siemens Medical Solutions USA
There is
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