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

Boston Scientific Recalls Cryoablation System Over Safety Hazard

Boston Scientific recalled 19 units of the ICEfx Cryoablation System on August 18, 2025. The recall stems from improperly tightened end caps on certain desiccant tube subassemblies. Patients and healthcare providers should stop using the device immediately.

Boston Scientific
Certain desiccant
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HIGHFDA DRUG

Amneal Pharmaceuticals Recalls Chlorpromazine Hydrochloride Tablets

Amneal Pharmaceuticals recalled 3,363 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025. The recall stems from the presence of a microorganism in packaging material. No microorganisms were detected in the tablets themselves, but consumers should stop using the product immediately.

Chlorpromazine Hydrochloride
Presence of
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HIGHFDA DRUG

Amneal Pharmaceuticals Recalls Sulfamethoxazole Tablets Over Hazard

Amneal Pharmaceuticals recalled over 133,000 bottles of Sulfamethoxazole and Trimethoprim Tablets on August 18, 2025. The recall stems from the detection of a microorganism in the packaging material, raising health concerns. No microorganisms were found on the tablets themselves.

SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
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HIGHFDA DRUG

Amneal Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination Risk

Amneal Pharmaceuticals recalled 13,130 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025, due to contamination concerns. The recall affects specific lots identified by their lot numbers AM240147, AM240148, AM240664, and AM240665. Consumers should stop using the tablets immediately and contact their healthcare provider for further guidance.

Chlorpromazine Hydrochloride
Presence of
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HIGHFDA DEVICE

Aesculap AG Recalls Surgical Instrument Due to Mislabeling

Aesculap AG recalled three surgical instruments on August 18, 2025, due to mislabeling issues. The ELAN 4 FIXED DURAGUARD LONG was incorrectly labeled as "Standard" and vice versa. The recall affects devices distributed in the U.S. and several international markets.

Aesculap AG
Mislabeling. The
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HIGHFDA DEVICE

CORNEAT VISION Recalls EverPatch+ Due to Conjunctival Wound Risk

CORNEAT VISION recalled 180 units of EverPatch+ on August 18, 2025, due to a risk of conjunctival wound dehiscence. This defect may lead to early exposure of the surgical patch. The recall affects distribution across the United States and several countries.

CORNEAT VISION
Reviewed complaints
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HIGHFDA DEVICE

CorNeat Vision Recalls Surgical Matrix Over High Dehiscence Risk

CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.

CorNeat Vision
Reviewed complaints
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HIGHFDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to High Risk

Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to critical failure modes. The recall affects devices distributed globally since August 15, 2025. Users must stop using the device immediately and follow manufacturer instructions.

Maquet Cardiovascular
Three failure
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HIGHFDA DEVICE

ETHICON Recalls Tissue Control Device for Barb Non-Engagement Risk

ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.

ETHICON
Potential for
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HIGHFDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Hazard

Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.

Exactech
Reverse Shoulder
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HIGHFDA DEVICE

Mindray Recalls BeneVision N1 Patient Monitor Over Alarm Issues

Mindray DS USA, Inc. recalled 2,278 BeneVision N1 Patient Monitors on August 15, 2025. The monitors may activate an abnormal alarm pause, compromising patient safety. Health professionals must cease using these devices immediately and follow recall instructions.

Mindray DS USA, Inc.
Potential for
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HIGHFDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluders Over High Hazard

Maquet Cardiovascular recalled the Heartstring III Proximal Seal System on August 15, 2025, due to three identified failure modes. These failures include issues with the seal's loading, deployment, and hemostasis. The recall affects 168 units distributed worldwide.

Maquet Cardiovascular
Three failure
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Over High HGB Risk

Beckman Coulter recalled the UniCel DxH 600 Cellular Analysis System on August 13, 2025. The devices may produce erroneously high hemoglobin results in patients with elevated white blood cell counts. This recall affects medical facilities worldwide, including the United States.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Over High HGB Results

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System on August 13, 2025. Erroneously high hemoglobin results may occur in patients with elevated white blood cell counts. Healthcare providers and patients must stop using the device immediately.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Hematology Analyzer Recalled for High HGB Risk

Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled 24 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. The issue stems from a misalignment in a component after replacement. Health providers must stop using these devices immediately.

Philips North America
The patient
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