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

3,494 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
Food & Beverages
HIGH
FDA 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:
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Food & Beverages
HIGH
FDA FOOD

The Candy Barn Recalls Chocolate Walnut Fudge Over Allergen Risk

The Candy Barn recalled 665 packages of Chocolate Walnut Fudge on August 6, 2025. The product does not list walnut and egg allergens in the 'contains' statement. Consumers should not consume the fudge and seek refunds or replacements.

The Candy Barn
Allergen labeling:
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Beta Sitosterol 715mg Recalled for Unapproved Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol supplement distributed nationwide from Norcross, Georgia after regulators flagged unapproved drug claims and misbranding. The product claims cardiovascular support and cholesterol benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by letter.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Slimaglutide 85,950-Unit Recall for Unapproved Drug Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Slimaglutide weight loss supplement distributed to more than 40 states. The recall cites unapproved drug claims and misbranding. Consumers who purchased Slimaglutide should not use it and should contact Hi-Tech Pharmaceuticals for refund or replacement per the recall notice.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals L-Glutamine Ultra Pure Powder Recall: 85,950 Units (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of L-Glutamine Ultra Pure Powder distributed to multiple retailers after FDA enforcement over unapproved drug claims. The product’s labeling asserts drug-like benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by mail to 6015-B Unity Drive, Norcross, GA 30071.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Formutech Nutrition Joint Formula Recalled for Unapproved Drug Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Formutech Nutrition Flexible Joint Formula with Cissus Quadrangularis sold nationwide after regulators flagged unapproved drug claims. The product claims to support tendons and muscles and promote healthy cartilage, which regulators say is not approved. Consumers who purchased the supplement should not use it and should await refund or replacement,'

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Adderex XR Recall 85,950 Units for Unapproved Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Adderex XR Strongest Focusing Aid sold nationwide after regulators found unapproved drug claims and misbranding. The product claims to boost concentration without a prescription. Consumers who bought the product should not use it and should contact the company for a refund or replacement.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA DEVICE

SeaSpine Orthopedics Recalled 74 Reef TA Inserter Instruments for Reef Interbody System (2025)

SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn

SeaSpine Orthopedics
Inserter, used
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Food & Beverages
HIGH
FDA FOOD

Prime Nutrition PhytoForm Fruits & Greens Recall 85,950 Units Over Unapproved Drug Claims (2025)

Prime Nutrition PhytoForm Fruits & Greens Formula recall affects 85,950 units distributed nationwide. Hi-Tech Pharmaceuticals Inc. will handle refunds or replacements. The product carries unapproved drug claims and is misbranded. Consumers who purchased this product should not consume it and should contact the company for refund or replacement information.

Prime Nutrition
Unapproved Drug
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Food & Beverages
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Recalls PrimeNutrition PhytoForm Fruits & Greens Formula 30 Servings for Unf

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula dietary supplement on Aug. 6, 2025. The product was manufactured by Prime Nutrition and distributed nationwide. The recall cites unapproved drug claims and misbranding. Consumers should not use the product and should contact Hi-Tech Pharmaceuticals for refund or replacement.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Food & Beverages
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals’ PrimeNutrition PhytoForm Fruits & Greens Recall for Unapproved Drug Claims

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula after FDA enforcement flagged unapproved drug claims and misbranding. The dietary supplement was distributed to 40+ states before the recall was issued on 2025-08-06 and remains active. Consumers should not consume the product and should seek refund or replacement from Hi-Tech Pharmaceuticals.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol 12.5 mg Tablets Recalled for NNCI Impurity Exceeding FDA Limit (2025)

Glenmark Pharmaceuticals Inc., USA recalls 17,496 bottles of Carvedilol tablets sold nationwide after NNCI impurity exceeded FDA limits. The recall covers lot numbers 17241257, 17241258, and 17241279 with Exp. Date 06/2026. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.

Glenmark Pharmaceuticals Inc.
CGMP Deviations:
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals PrimeNutrition Taurine Recall 85,950 Units in 2025

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition Taurine Mental & Athletic Performance dietary supplement distributed nationwide. The FDA enforcement report cites unapproved drug claims and misbranding. Consumers who purchased this product should not consume it and should contact the company for refund or replacement.

Hi-Tech Pharmaceuticals
Unapproved Drug
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units

Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.

Olympus Corporation of the Americas
Potential for
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Fish Oil EPA/DHA Omega-3 Soft Gels Recalled for Unapproved Drug Claims (85,,

Hi-Tech Pharmaceuticals recalled 85,950 units of Fish Oil Heart and Brain Health EPA/DHA Omega-3 soft gels distributed nationwide after regulators flagged unapproved drug claims. The FDA enforcement notice identifies unapproved health claims associated with the product. Consumers who bought this product should stop using it and contact Hi-Tech Pharmaceuticals for refunds or replacements.

Hi-Tech Pharmaceuticals
Unapproved Drug
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