In the first half of 2025, the U.S. Food and Drug Administration (FDA) issued a total of 141 recalls, of which 110 were related to food and beverage products—accounting for nearly 80% of all notices. This high proportion underscores the significant risk associated with this product category and the continued vigilance of regulatory authorities.

Breakdown of Recalls by Product Category:

• Food and Beverages: 110 cases.
• Dietary Supplements, Enhancement Products, Drugs: 16 cases.
• Animal & Veterinary Products, Pet Food: 10 cases.
• Medical Devices: 7 cases.
• Cosmetics: 1 case.

PART I: DETAILED ANALYSIS OF FOOD AND BEVERAGE RECALLS

The majority of food-related recalls were attributed to undeclared allergens, microbial contamination, and the presence of chemical contaminants.

1. Allergen-Related Recalls – 63 cases

• Allergen recalls were primarily due to labeling errors, specifically the failure to declare known allergens on product packaging. Among the most frequently undeclared allergens:

• Milk: Involved in approximately 25 recalls, commonly found in chocolate, cookies, snacks, and sauces.
• Wheat (gluten): Frequently associated with bread, frozen foods, and baked goods.
• Soy, eggs, sesame, and peanuts: Found in a wide range of processed and ready-to-eat products.

• These recalls often involved sweet snacks and convenience foods—products with complex ingredient profiles that are prone to labeling oversights. Failure to declare allergens not only violates FDA labeling regulations but also poses serious health risks, particularly for children and individuals with food allergies.

2. Microbiological Hazards – 38 cases

• Microbial contamination accounted for a significant portion of food recalls, with the following pathogens most commonly identified:

• Salmonella: Responsible for 20 recalls, typically found in raw meat, eggs, and fresh produce.
• Listeria monocytogenes: Involved in 12 cases, frequently detected in cheese, celery, and mushrooms.
• Clostridium botulinum: Though less common (3 cases), this pathogen is extremely dangerous and was found in canned vegetables and herring products.

• These recalls highlight the critical importance of maintaining strict hygiene and temperature control throughout the production, storage, and distribution chain. Microbial contamination can lead to severe foodborne illnesses and, in some cases, fatal outcomes if not promptly addressed.

3. Contaminants – 3 cases

• A small number of recalls were linked to the presence of heavy metals such as lead and arsenic at levels exceeding regulatory limits. These contaminants were primarily found in dietary supplements and infant nutrition products.
• While less frequent, such hazards pose a high level of risk, particularly to vulnerable populations such as infants and individuals with compromised health.

Data from Q1 and Q2 2025 indicates that the food industry continues to face significant challenges in ensuring product safety and regulatory compliance. The most frequently recalled products in the U.S. included chocolate, cookies, snacks, salads, sauces, and frozen foods. Several brands were subject to repeated recalls, particularly among manufacturers of convenience foods, imported goods from Asia, and dietary supplements.

To mitigate the risk of recalls and ensure compliance with FDA regulations, food exporters are advised to:

• Conduct thorough reviews of allergen labeling practices.
• Strengthen microbiological testing protocols and implement HACCP systems.
• Rigorously monitor raw material quality to prevent contamination with heavy metals or undeclared substances.
• Maintain transparent and well-documented compliance records for all products.
• Provide ongoing training for staff on international food safety standards, including FSMA and labeling regulations.

PART II: NON-FOOD RECALLS – “OTHER” HAZARD TYPES

In addition to food-related recalls, the FDA also issued 34 recalls involving medical devices, drugs, and cosmetics. Medical device recalls were primarily due to safety concerns, including contamination risks from improper reprocessing or design flaws. Drug recalls were often triggered by the detection of impurities or undeclared active pharmaceutical ingredients, particularly in enhancement supplements. Although only one cosmetic recall was recorded, it involved microbial contamination in a shampoo product - highlighting the importance of hygiene even in non-ingestible consumer goods.

These findings reinforce the need for comprehensive quality control across all consumer health products, especially those applied to or ingested by the human body.

PART III: CONCLUSION

The recall data from the first half of 2025 not only highlights persistent safety challenges in the food sector but also reveals broader vulnerabilities across the entire consumer health product supply chain. From food and supplements to drugs, medical devices, and cosmetics, the recalls underscore the critical importance of robust quality assurance systems and strict regulatory compliance.

Ensuring product safety is not merely a regulatory obligation - it is a fundamental responsibility of manufacturers and a prerequisite for maintaining consumer trust and long-term market access.