All Product Recalls

Browse through 1,540 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DRUG

Exela Pharma Recalls Sodium Bicarbonate Injection Over Arsenic Risk

Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.

SODIUM BICARBONATE
Failed Impurities/Degradation
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HIGHFDA DEVICE

Fortress Introducer Sheath System Recalled Due to Labeling Error

Contract Medical International GmbH recalled 2,500 Fortress Introducer Sheath Systems on July 30, 2025. Units may have incorrect pouch labeling, leading to potential use of the wrong device version. Patients and healthcare providers should stop using the product immediately.

Contract Medical International GmbH
Units may
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HIGHFDA DEVICE

S.I.N. Implant System Recalls Dental Implants Over Quality Concerns

S.I.N. Implant System Ltda recalled 4,367 dental implants on July 30, 2025, due to improper storage conditions. The recalled products may have compromised packaging, affecting their quality and performance. Patients and healthcare providers should stop using these devices immediately.

S.I.N. Implant System Ltda
Dental implants
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Due to Calibration Failures

Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DRUG

Pfizer Recalling Levoxyl Due to Subpotent Drug Hazard

Pfizer Inc. recalled 29,004 bottles of Levoxyl on July 29, 2025, due to subpotency. The recall affects levothyroxine sodium tablets, 50 mcg, Rx only, distributed in the U.S. Consumers should stop using the product immediately.

Levoxyl
Subpotent drug
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Over Calibration Failures

Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DEVICE

ORTOMA Inserter Adapter Recalled Due to Weld Breakage Hazard

ORTOMA AB recalled 261 Inserter Adapters on July 28, 2025, due to a potential weld failure. The defect poses a risk of improper positioning during hip implant procedures. The recall affects devices distributed worldwide, including the U.S. and countries like Japan and Sweden.

ORTOMA AB
Due to
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HIGHFDA DEVICE

Medline Recalls Intubation Trays Due to Light Failure Hazard

Medline Industries, LP recalled 2,520 medical convenience kits on July 25, 2025. The recall affects multiple intubation trays containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The light in these devices fails to illuminate, posing a serious risk in emergency situations.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Laryngoscope Light Failure

Medline Industries, LP recalled 596 medical convenience kits on July 25, 2025. The recall affects kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light failure. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Merit Medical Recalls Hemostasis Valve Over Foreign Body Risk

Merit Medical Systems recalled 447 units of the 10Fore Hemostasis Valve on July 25, 2025. A manufacturing issue may cause a deformed silicone quad ring, posing a risk of foreign body in the fluid pathway. This recall affects the U.S. and Canada.

Merit Medical Systems
Due to
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HIGHFDA DRUG

Duloxetine Capsules Recalled Due to High N-nitroso Impurity

Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.

DULOXETINE
CGMP Deviations:
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HIGHFDA DRUG

Cipla USA Recalls Albuterol Inhalation Aerosol for Stability Issues

Cipla USA, Inc. recalled 20,352 packs of Albuterol Sulfate inhalation aerosol on July 24, 2025. The recall follows out-of-specification results in particle size distribution during stability testing. Consumers must stop using the product immediately.

Cipla USA Inc.
Failed Stability
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Recalled Aiho Five-Drawer Dresser (front)
HIGH
CPSC

Aiho Dressers Recalled Over Serious Tip-Over Risk

Aiho recalled five-drawer dressers on July 24, 2025, due to tip-over and entrapment hazards. The dressers, model number AP23-W, do not meet safety standards set by the STURDY Act. Consumers should stop using the product if it is not anchored to a wall.

Aiho Dressers
The recalled
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