All Product Recalls

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

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 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 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 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 FOOD

Toto Foods Recalls S'Mores Cookies Over Soy Allergy Risk

Toto Foods recalled 120,180 units of S'Mores Ooey Gooey Cookies on August 20, 2025. The product label conflicts regarding soy content pose a health risk to consumers with soy allergies. The cookies were distributed across 13 states including California and New York.

Toto Foods
Product label
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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 Cardiac Pacemakers Over Safety Risk

Boston Scientific recalled 1,050 cardiac pacemakers on August 20, 2025. The recall affects the VISIONIST and ACCOLADE families of devices due to a software issue. Patients must stop using the devices immediately to prevent potential safety risks.

Boston Scientific
Software to
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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 Due to High Battery Risk

Boston Scientific recalled 3,146 units of the L209 PROPONENT DR (VDD) SL Pacemaker on August 20, 2025. The recall addresses a software issue that may cause device malfunction in ambulatory settings. Patients should stop using the device and follow manufacturer instructions immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ESSENTIO SR SL MRI Pacemaker Over Safety Software Issue

Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from their healthcare provider.

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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