Drug Recalls Center

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

514
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

Abbott Point Of Care Recalls i-STAT EG7+ Cartridges Over Clearance Issues

Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated measurement ranges. This issue affects the accuracy of potassium and ionized calcium tests, posing a high risk to patients.

Abbott Point Of Care
Lack of
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HIGHFDA DEVICE

Folsom Metal Products Recalls Distraction Pins Over Labeling Issues

Folsom Metal Products recalled 160 units of distraction pins due to unvalidated shelf life labeling. The recall affects devices distributed across multiple states, including California and Texas. Patients and healthcare providers should stop using the product immediately.

Folsom Metal Products
Labeling includes
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HIGHFDA DEVICE

Abbott Point Of Care Recalls i-STAT CG4+ Cartridge Over Clearance Issues

Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance reflecting updated sample types and measurement ranges. Healthcare providers must stop using the device immediately and follow recall instructions.

Abbott Point Of Care
Lack of
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HIGHFDA DEVICE

Medline Recalls Catheter Kits Due to Shape Retention Issues

Medline Industries recalled 828 units of catheter kits on August 21, 2025, due to potential shape retention issues. The affected products include Model Numbers DYNJ0415366P and DYNJ0415366Q. This recall poses a serious risk to patient safety.

Medline Industries, LP
The kits
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HIGHFDA DRUG

Baxter Healthcare Recalls Acetaminophen Injection Over Discoloration Risk

Baxter Healthcare Corporation recalled 13,000 containers of Acetaminophen Injection on August 20, 2025. The recall follows reports of discoloration that may affect product safety. Consumers should stop using the medication immediately and contact their healthcare providers for guidance.

Baxter Healthcare Corporation
Discoloration
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Carvedilol Tablets Over Impurity Hazard

Major Pharmaceuticals recalled 26,628 cartons of Carvedilol Tablets on August 20, 2025. The recall stems from N-Nitroso Carvedilol Impurity-1 levels exceeding FDA limits. Consumers should stop using the product immediately and consult their healthcare provider.

Major Pharmaceuticals
CGMP Deviations:
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HIGHFDA DEVICE

Boston Scientific Recalls ESSENTIO DR SL MRI Pacemaker Due to Software Risk

Boston Scientific recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device immediately and follow the manufacturer’s instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemaker Over Software Hazard

Boston Scientific recalled 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ACCOLADE SR SL Pacemakers Over Software Issue

Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Over Software Safety Risk

Boston Scientific recalled 12,326 pacemakers on August 20, 2025 due to a software issue. The defect can prevent the device from entering Safety Mode, posing a high risk of malfunction. Patients should stop using the devices and follow recall procedures immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ALTRUA 2 Pacemaker Over Safety Software

Boston Scientific recalled 4,841 ALTRUA 2 SR SL pacemakers on August 20, 2025. The recall stems from a software issue that may prevent proper device function in patients. Users should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemaker Over Software Issue

Boston Scientific recalled 3,592 units of the Model L221 PROPONENT DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that may prevent proper device functioning due to high battery impedance. Patients and healthcare providers must stop using the device immediately and follow the recall instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Over High Battery Impedance Risk

Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Due to Software Hazard

Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer instructions.

Boston Scientific
Software to
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