Key facts
- Multiple infant formula brands have been recalled recently due to bacterial contamination.
- Experts attribute the FDA's inadequate preparation to staff cuts and reorganization under the Trump administration.
- Operation Stork Speed, an FDA initiative to improve infant formula safety, has reportedly stalled.
- Nara Organics and ByHeart formulas were recalled, with both linked to a shared whole milk powder supplier.
- A lawsuit alleges a baby contracted botulism from Nara Organics' formula, which was voluntarily recalled.
- The FDA found deficiencies at Nara Organics' facilities and is investigating supply chain contamination.
- New Zealand authorities discovered contamination in A2 Platinum Premium formula, leading to a US recall.
Multiple brands of infant formula have been recalled recently due to bacterial contamination, with experts suggesting the Food and Drug Administration (FDA) is ill-equipped to handle the threat following staff reductions during the Trump administration. Operation Stork Speed, an FDA initiative launched to improve infant formula safety, has reportedly seen little progress since the summer of 2025, according to one advisor.
Tom Brenna, a professor and advisor on the initiative, expressed regret over the lack of movement. However, an FDA spokesperson stated that the operation is continuing as planned and that the agency has more than doubled its infant formula staffing, while also requesting Congress mandate greater industry accountability, such as requiring companies to report positive pathogen testing.
Critics, including Sarah Mayne, former director of the FDA’s center for food safety and applied nutrition, argue that the agency's workforce, particularly its boots-on-the-ground inspectors, has been significantly reduced, leading to a diminished capacity to prevent contamination. The FDA spokesperson did not directly address questions about cuts to inspectors.
In the past year, several infant formula brands have faced recalls in the U.S. In late June, a lawsuit was filed against Nara Organics after a baby allegedly contracted botulism from the company's formula. Nara Organics had voluntarily recalled its product earlier that month. Investigative findings revealed that Nara Organics used whole milk powder from Organic West, the same supplier for ByHeart, which recalled its formula in November of the previous year due to an infant botulism outbreak linked to 48 hospitalizations across 17 states.
Infant formula safety is a critical mission for the FDA, which mandates annual inspections for manufacturers, though not for ingredient suppliers. In light of the FDA's reduced capacity, states are assuming more responsibility for food safety regulation. However, a source familiar with FDA operations noted that states do not always coordinate effectively on shared contamination risks, potentially slowing safety efforts. Data from Steven Mandernach, executive director of the Association of Food and Drug Officials, indicated that states conducted nearly 2,000 recall checks in the first week of the ByHeart response, compared to only 21 by the FDA.
The whole milk powder in both contaminated formulas was produced in Nevada. ByHeart and Nara Organics formulas are manufactured in Iowa and Germany, respectively. The FDA inspected Nara Organics' facilities and found deficiencies, which the company stated it is addressing with voluntary corrective actions. A June advisory from the California department of public health linked three infant botulism cases to Nara Organics' formula.
The FDA spokesperson noted that there is insufficient evidence to confirm whole milk powder as the source of contamination and that the agency is continuing its investigation. A ByHeart spokesperson stated the company learned of the shared supplier only recently and that the FDA's investigation is now focusing on third-party ingredients.
Teams responsible for imported food safety are in a particularly vulnerable position, according to Mayne and the source familiar with FDA operations. Concerns about infant formula imported from abroad are significant. Earlier this year, the European Union initiated a precautionary global recall of several infant formula brands due to concerns about cereulide. Subsequently, the FDA issued a recall alert for A2 Platinum Premium infant formula manufactured in New Zealand and sold only in the U.S., also due to cereulide contamination. The contamination was discovered by New Zealand's food regulation authority, not the FDA.
Mayne concluded that the FDA is one part of a multi-agency food safety system that has been damaged by the Trump administration's actions, with additional risks posed by factors like climate change.