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

630 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 FOOD

Wegmans Cheese Flight Recalled Due to Listeria Contamination

Wegmans Food Markets recalled 4,884 units of its Assorted Cheese Flight on August 12, 2025. The product may be contaminated with Listeria monocytogenes, a serious foodborne pathogen. The recall affects consumers in NY, PA, MA, NJ, MD, VA, NC, DE, CT, and DC.

Wegmans Food Markets
Products may
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HIGHFDA DEVICE

Applied Medical Technology Recalls Nasal Feeding Tubes Over Detachment Risk

Applied Medical Technology recalled 390 NutraGlide Nasal Feeding Tubes on August 12, 2025, due to a risk of distal tips detaching. This recall affects models distributed in Massachusetts and Rhode Island. Patients and healthcare providers must stop using these devices immediately.

Applied Medical Technology
The nasal
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Over False Negatives

Agilent Technologies recalled 67 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from the potential for weak staining leading to false negative results in B-cell identification. Healthcare providers must cease use immediately and follow recall instructions.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Due to Staining Issues

Agilent Technologies Denmark ApS recalled 65 units of its FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 on August 11, 2025. The recall stems from potential weak staining that could lead to false negative CD20 identification. Healthcare providers and patients should stop using the product immediately.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DRUG

Lannett Recalls Lisdexamfetamine Capsules Over Labeling Error

Lannett Company recalled 8,544 bottles of Lisdexamfetamine Dimesylate Capsules on August 11, 2025. The recall occurred due to a labeling mix-up where 40 mg capsules were mislabeled as 30 mg. This issue poses a high risk to consumers who may receive incorrect dosages.

Lisdexamfetamine Dimesylate
Labeling: Label
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Due to False Negatives

Agilent Technologies Denmark ApS recalled 4,145 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from potential weak staining that may lead to false negative CD20 identification. Healthcare providers and patients must stop using the product immediately.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DRUG

Quallent Pharmaceuticals Recalls Duloxetine Capsules Over Impurity Risk

Quallent Pharmaceuticals recalled 3,591 bottles of Duloxetine Delayed-Release Capsules on August 8, 2025. The recall stems from CGMP deviations regarding an impurity exceeding safety limits. Consumers should stop using the product immediately and contact their healthcare provider.

DULOXETINE
CGMP deviations:
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HIGHFDA FOOD

SUNGAL Canned Half Plum Recalled Due to Cyclamate Contamination

SUNGAL recalled 29 cases of canned Half Plum on August 8, 2025, due to cyclamate adulteration. The affected product may pose a health risk. Consumers in California, Maryland, New York, and Virginia should stop using the product immediately.

SUNGAL
Cyclamate adulteration
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HIGHFDA DEVICE

Philips Medical Systems Recalls IntelliSpace Cardiovascular Software

Philips Medical Systems Nederland B.V. recalled its IntelliSpace Cardiovascular Software 8.0.0.4 on August 8, 2025. The recall affects four units distributed nationwide, particularly in Georgia, North Carolina, and Texas. The software displays outdated information, posing a significant risk to patient safety.

Philips Medical Systems Nederland B.V.
Software issue
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Theophylline Tablets Over Dissolution Issues

Glenmark Pharmaceuticals Inc. recalled 22,656 bottles of Theophylline extended-release tablets on August 8, 2025. The recall follows reports of failed dissolution specifications that could impact medication efficacy. Consumers should stop using the product and consult healthcare providers immediately.

Glenmark Pharmaceuticals Inc.
Failed Dissolution
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HIGHFDA DEVICE

Medline Recalls Sterile Convenience Kits Due to Sterilization Issue

Medline Industries recalled 22 sterile convenience kits on August 8, 2025, after discovering they had not been sterilized. The affected models include DYNJ0382730O and DYNJ61038B. This recall impacts states including Florida, Maryland, New Jersey, and Tennessee.

Medline Industries, LP
Convenience kits
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HIGHFDA DEVICE

Schiller Ag Recalls Argus PB-3000 Due to Error Message Hazard

Schiller Ag recalled 266 units of the Argus PB-3000 on August 8, 2025. The vital sign monitoring instrument may trigger an error message during blood pressure measurements. The recall affects devices distributed nationwide in Montana, Wisconsin, and Illinois.

Schiller, Ag
Vital sign
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HIGHFDA DEVICE

Medline Recalls Sterile Convenience Kits Due to Sterilization Failure

Medline Industries recalled 88 units of its Sterile Convenience Kits on August 8, 2025. The kits were labeled as sterile but did not undergo the required sterilization process. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Convenience kits
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Recalled Séfralls Minoxidil Hair Generation Serum
HIGH
CPSC

Séfralls Hair Serum Recalled Over Child Poisoning Risk

Guangzhou Ariel Biotech recalled Séfralls Hair Generation Serum on August 7, 2025. The recall affects an unknown number of units due to the product's non-compliance with child-resistant packaging standards. The defective packaging poses a serious poisoning risk to children if ingested.

Guangzhou Ariel Biotech
The hair
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Recalled Pet Zone Laser Pointer and LED Ball Pet Toys
HIGH
CPSC

Petmate Recalls Pet Zone Toys Due to Ingestion Hazard

Petmate recalled Laser Pointer and LED Ball pet toys on August 7, 2025, due to a serious ingestion risk. The toys, sold exclusively at Menards, contain button cell batteries that can be accessed by children. Consumers should stop using them immediately and seek a full refund.

Petmate
The recalled
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