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

Gina Marie Bakery Recalls Cookies Over Undeclared Color Additives

Gina Marie Bakery recalled 172 cases of Vanilla Cookies with Raspberry Peach Jam due to undeclared Red 3 and Blue 1. The recall was initiated on September 10, 2025, after notification to the FDA. Consumers should not consume the product and seek refunds.

Gina Marie Bakery
Undeclared Red
Read more
HIGHFDA FOOD

Gina Marie Bakery Recalls Cookies Over Undeclared Ingredients

Gina Marie Bakery recalled 172 cases of Italian Sesame Cookies on September 10, 2025. The recall was initiated due to undeclared sesame and artificial colors. Consumers should not consume these cookies and can seek a refund.

Gina Marie Bakery
Undeclared Sesame,
Read more
HIGHFDA FOOD

Gina Marie Bakery Recalls Cookies Over Undeclared Dyes

Gina Marie Bakery recalled 172 cases of Vanilla with Apricot Jam Cookies on September 10, 2025. The recall follows the discovery of undeclared Red 40 and Yellow 6 in the product. Consumers should not eat these cookies and seek refunds.

Gina Marie Bakery
Undeclared Red
Read more
HIGHFDA DEVICE

Biomet Recalls Juggerknot Mini Soft Anchors Due to Labeling Error

Biomet recalled 40 units of Juggerknot Mini Soft Anchors on September 9, 2025. The recall stems from a labeling error where the carton contains 1.4mm Short devices instead of the labeled 1.0mm Mini products. Patients and healthcare providers must stop using these devices immediately.

Biomet
The outer
Read more
HIGHFDA FOOD

Whole Foods Market Granola Recalled Due to Allergen Risk

Whole Foods Market recalled Blueberry Almond Granola on September 9, 2025. The product contains undeclared allergens including wheat, sesame, and cashew. Six units, packaged in one-pound containers, were sold at one store in Philadelphia, PA.

WFM Purchasing, LP
Product was
Read more
HIGHFDA FOOD

Lee K of NY Recalls Kimchi Mackerel Over Undeclared Allergens

Lee K of NY Inc. recalled 43 units of Aged Kimchi Mackerel on September 8, 2025. The product contains undeclared milk and shrimp, posing a serious allergy risk. Consumers in New York and New Jersey should stop using the product immediately.

Lee K of NY
Product contains
Read more
HIGHFDA DRUG

Sandoz Recalls Cyclophosphamide Injection Over Safety Concerns

Sandoz Inc. recalled 263 vials of Cyclophosphamide Injection on September 5, 2025. The recall follows cGMP deviations related to temperature excursions during transportation. Healthcare providers and consumers must stop using the product immediately.

Sandoz
cGMP deviations:
Read more
HIGHFDA DEVICE

GE Medical Systems Recalls AW Server Models Over Data Security Risk

GE Medical Systems recalled 7,302 AW Server units on September 5, 2025, due to a critical security vulnerability. The flaw could allow unauthorized access to sensitive patient data. Healthcare providers and patients must cease use immediately and follow recall procedures.

GE Medical Systems
Firm has
Read more
HIGHFDA DRUG

Apotex Recalls Ketorolac Ophthalmic Solution Over Sterility Concerns

Apotex Corp. recalled 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

KETOROLAC TROMETHAMINE
Lack of
Read more
HIGHFDA DRUG

Apotex Recalls Ophthalmic Solution Over Sterility Concerns

Apotex Inc. recalled 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider or Apotex Corp.

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Lack of
Read more
Recalled AR-15 Chamber Lock Pro (Red)
HIGH
CPSC

StopBox USA Recalls AR-15 Chamber Lock Pro Due to Injury Risk

StopBox USA recalled AR-15 Chamber Lock Pro firearm locks on September 4, 2025. A manufacturing defect allows unauthorized access to firearms, posing a risk of serious injury or death. Consumers should immediately stop using the locks and contact StopBox for refunds or replacements.

StopBox USA
A manufacturing
Read more
HIGHFDA DRUG

Zydus Pharmaceuticals Recalls Entecavir Tablets Over Impurity Risk

Zydus Pharmaceuticals recalled 4,440 bottles of Entecavir Tablets on September 4, 2025. The recall follows failure to meet impurity and degradation specifications. Consumers should stop using the affected tablets immediately and contact their healthcare provider.

Zydus Pharmaceuticals USA Inc.
Failed Impurity/Degradation
Read more
HIGHFDA FOOD

Organicare Nature's Science Recalls FemiClear Supplement Over E. Coli Risk

Organicare Nature's Science recalled 15,075 bottles of FemiClear Daily Bladder Strength Dietary Supplement on September 4, 2025. The recall stems from microbial contamination with E. coli O7:K1 and E. coli 1303. Consumers should not consume the product and seek refunds immediately.

Organicare Nature's Science
Microbial contamination
Read more
Advertisement