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

621 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

Hi-Tech Pharmaceuticals Recall Dietary Supplement Over Misbranding

Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol on August 6, 2025 due to unapproved drug claims. The product supports cardiovascular health but lacks proper approval. Consumers should stop using the supplement immediately and contact the company for a refund.

Hi-Tech Pharmaceuticals
Unapproved Drug
Read more
HIGHFDA FOOD

The Candy Barn Recalls Chocolate Pecan Fudge Over Allergen Risk

The Candy Barn recalled 665 packages of Chocolate Pecan Fudge on August 6, 2025. The product lacks proper allergen labeling for pecans and eggs, posing a high risk to consumers. The recall affects products distributed in Kalona, Iowa.

The Candy Barn
Allergen labeling:
Read more
HIGHFDA FOOD

Hi-Tech Pharmaceuticals Recalls Taurine Supplement Over Misbranding

Hi-Tech Pharmaceuticals recalled 85,950 units of its Taurine Mental & Athletic Performance dietary supplement on August 6, 2025. The company faces scrutiny for unapproved drug claims and misbranding. Consumers are urged to stop using the product immediately.

Hi-Tech Pharmaceuticals
Unapproved Drug
Read more
HIGHFDA FOOD

The Candy Barn Recalls English Toffee Over Allergen Mislabeling

The Candy Barn recalled 665 packages of English Toffee on August 6, 2025. The product contains undeclared pecans, posing a risk to those with tree nut allergies. Consumers should not eat the candy and should seek a refund or replacement.

The Candy Barn
Allergen labeling:
Read more
HIGHFDA DEVICE

Getinge Recalls VASOVIEW HEMOPRO 3 Vessel Harvesting System

Getinge recalled 98 units of the VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting System on August 5, 2025. The recall addresses out-of-box failures including malfunctioning jaws and heater wires. No serious injuries were reported related to these failures.

Maquet Cardiovascular
On August
Read more
HIGHFDA DEVICE

SEASPINE Orthopedics Recalls Surgical Inserter Over Implant Risks

SEASPINE Orthopedics recalled 74 units of the Reef TA Inserter on August 6, 2025. The device may cause difficulties in disengaging implants, leading to prolonged surgeries. Healthcare providers should stop using the device immediately and follow recall instructions.

SEASPINE ORTHOPEDICS
Inserter, used
Read more
HIGHFDA DEVICE

Philips Medical Systems Recalls Radiation Therapy Planning Software

Philips Medical Systems recalled 810 units of its Radiation Therapy Planning System on August 5, 2025. A software issue may cause image errors during treatment planning. Affected models include Pinnacle TumorLOC and Multimodality Simulation Workspace.

Philips Medical Systems
Due to
Read more
HIGHFDA DEVICE

Boston Scientific NephroMax Kit Recalled Over Foreign Material Risk

Boston Scientific recalled 458 NephroMax Kits on August 5, 2025, due to contamination risk. The Encore 26 Inflation Device may allow foreign particles to enter balloon dilatation catheters. Patients must stop using the device immediately and follow recall instructions.

Boston Scientific
The Encore
Read more
HIGHFDA DRUG

Haleon US Holdings Recalls Sensodyne Toothpaste Due to Label Mix-Up

Haleon US Holdings recalled 46,692 tubes of Sensodyne PRONAMEL toothpaste on August 5, 2025, due to a labeling mix-up. The outer carton states Fresh Mint while the tube claims Cool Mint/Whitening. The actual product inside is Fresh Mint, leading to potential consumer confusion.

Haleon US Holdings
Labeling: Label
Read more
HIGHFDA DRUG

Sandoz Recalls Enoxaparin Sodium Injection Due to Mislabeling

Sandoz Inc. recalled 10 bags of Enoxaparin Sodium Injection on August 5, 2025. Bags labeled for Enoxaparin Sodium 80 mg/0.8 mL contained the incorrect dosage of 30 mg/0.3 mL. Consumers and healthcare providers must stop using the product immediately.

ENOXAPARIN SODIUM
Correct Labeled
Read more
Advertisement