These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,247 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
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 FOOD

Itacate Foods Recalls Lentil Soup Over Undeclared Dyes

Itacate Foods recalled 154 packages of CAMPSITE LENTEJAS lentil soup on August 20, 2025. The recall follows the discovery of undeclared Yellow #5 and Yellow #6, which can cause allergic reactions. Consumers should stop using the product immediately.

Itacate Foods
Undeclared Yellow
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HIGHFDA FOOD

Itacate Foods Recalls Chilaquiles Over Undeclared Dyes

Itacate Foods recalled 566 packages of CHARGE-UP CHILAQUILES on August 20, 2025. The product contains undeclared Yellow #5 and Yellow #6, posing a health risk. Consumers should not consume the product and seek a refund or replacement.

Itacate Foods
Undeclared Yellow
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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 FOOD

Hostess Recalls Ding Dongs Due to Mold Contamination

Hostess recalled 60,630 cases of Ding Dongs on August 20, 2025, following reports of mold contamination. The recall affects various packaging sizes sold across multiple states. Consumers should not consume the product and seek refunds or replacements immediately.

The J.M. Smucker
Mold. The
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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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HIGHFDA DEVICE

Boston Scientific Recalls VALITUDE Pacemaker Over Software Issue

Boston Scientific recalled 3,620 VALITUDE CRT-P pacemakers on August 20, 2025, due to a software flaw. The issue may prevent the device from operating correctly in ambulatory settings. 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 ESSENTIO DR SL Pacemaker Over Safety Risk

Boston Scientific recalled 22,714 ESSENTIO DR SL pacemakers on August 20, 2025. Software updates are necessary to prevent initiation of Safety Mode due to high battery impedance. The recall affects multiple models including the ACCOLADE and VISIONIST series.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Proponent DR EL MRI Pacemaker Due to Hazard

Boston Scientific recalled 63,851 Proponent DR EL MRI Pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper device function in certain conditions. Patients must stop using the device and follow manufacturer instructions immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls VALITUDE CRT-P EL MRI Pacemakers Due to Safety Hazard

Boston Scientific recalled 28,911 VALITUDE CRT-P EL MRI pacemakers on August 20, 2025, due to a software issue that may prevent proper device function. The recall affects specific models from the ACCOLADE family of devices. Patients and healthcare providers should stop using these devices immediately.

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 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 Pacemakers Due to Software Hazard

Boston Scientific recalled 106,536 PROPONENT DR SL MRI pacemakers on August 20, 2025, due to software issues. The recall affects multiple models and aims to prevent safety mode initiation in ambulatory settings. Patients must stop using these devices immediately and follow the manufacturer's instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ALTRUA 2 DR Pacemaker Over Safety Hazard

Boston Scientific recalled 4,055 ALTRUA 2 DR SL Pacemakers on August 20, 2025, due to a software issue. This software can prevent the device from initiating Safety Mode in certain conditions. Patients should stop using the device immediately and follow recall instructions.

Boston Scientific
Software to
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