What Drove the 2025 FDA Recalls
New FDA and FSIS data demonstrate that food & beverage-based recalls hit an all-time high in 2025. Some data points we find the most interesting (from Food Safety News):
- 145 FDA recalls in Q3 2025, the second highest quarterly count since Q1 2020.
- 59 million pounds of FSIS regulated meat and poultry recalled in Q3, up from 1.04 million pounds in Q2 (+5,500%).
- 110 million FDA units recalled in 2025 (year to date), compared with 45 million at the same point in 2024.
- 13 million units recalled in Q3 due to bacterial contamination, primarily Listeria.
It is estimated that the FDA performs pathogen tests on only about 1-2% of the products they are responsible for (~80% of the U.S. food supply). The CDC estimates, as an example, that for every case of Salmonella illness reported, 29 go unreported. The good news is that the FDA considers any pathogen contamination impacting the product violative and not fit for distribution and use (zero tolerance).
The USDA, on the other hand, has declared limited instances of pathogen contamination to fit into the zero tolerance model, such as E. Coli (STEC) in ground meats or any pathogen in ready-to-eat products.
The USDA has taken the stance that pathogens in raw meat (except hamburger) is natural and to be expected, assuming that products will be properly cooked, and cross contamination will be controlled in the home, restaurant, manufacturing facility, etc. As an example, the standards for poultry are “…up to 25% of ground chicken, 13.5% of ground turkey, 15.4% of chicken parts, and 9.8% of whole chickens may test positive for Salmonella without triggering enforcement.” Even these standards aren’t firm. The USDA data shows many plants with consistent records of not meeting the official standards (as much as 100% of the time) just keep on producing.
Neither agency mandates specific sampling nor testing protocols for those companies that do pathogen testing on finished products. Such protocols are critical as poorly designed sampling plans or inadequate testing methodologies can limit, or almost guarantee, that a violative product will not be found prior to shipping.
FDA recall data show that undeclared allergens and bacterial contamination remained the dominant causes of food recalls in 2025. Other recall reasons included foreign material, chemical contamination and a rise in packaging and processing failures across the supply chain.
What Breaks Down in Finished Product Safety
Finished product failures can often be traced to a few common cause issues, such as.
- Products that are raw and untreated
- Products that are raw and use interventions that aren’t validated or not validated correctly
- Products that undergo further processing or handling post intervention but pre-final packaging
- Products where the intervention may result in sub-lethal damage that can allow the cell to repair during storage/handling (HPP)
Applying HACCP or Preventive Control principles to these situations would show that there is a finite risk of pathogen contamination and survival. These principles would not condone test and release programs to be viewed as proving the product is safe, only demonstrating that the specific sampling plan and testing protocol did not find contamination. In order to assure the final product is safe in these situations, they would need to be treated with a validated kill step.
Where Irradiation Could Have Prevented the Most Damage
While bacterial contamination events decreased in count from 2024 to 2025, the recalls tied to those events involved far larger product volumes. For example, bacterial contamination accounted for more than 13 million recalled units in Q3 alone.
This is the category where irradiation provides the clearest benefit. Traditional environmental monitoring and batch testing cannot detect every contamination event, especially in ready to eat foods where consumers do not perform a kill step.
What are the situations where irradiation could reduce the moral and legal risks by assuring inactivation of pathogens? Irradiation is most effective when used with products in the final package. Examples of high risk scenarios include:
- Products that are raw or untreated.
- Raw products that use interventions that are not validated or not properly validated.
- Products that undergo further processing and handling post intervention but pre-final packaging.
- Products and processes where the intervention may result in sub-lethal damage where the cells can repair themselves during storage and handling (HPP).
Irradiation directly reduces microbial load on finished products and ingredients, targeting pathogens such as Listeria, Salmonella and E. coli at the point where contamination poses the greatest risk. When a single lapse can trigger a nationwide recall, the ability to apply a validated microbial reduction step is one of the most powerful tools a food producer can add to its safety program.
How Producers Can Strengthen Their Food Safety Strategy
The increase in recall volume is a clear signal that companies need to reassess how they manage microbial and cross contact risks. A modern food safety strategy should include a combination of faster detection, stronger environmental control and the use of high energy technologies that reduce pathogens at the point of processing.
Irradiation can serve as a preventive layer that supports existing controls and stabilizes facilities that handle multiple ingredients, allergens or ready to eat foods. If you are reassessing your microbial control strategy in light of rising recall volumes, please book a call with our team so we can help you evaluate your irradiation strategy.
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