Beyond the Recall: What the By Heart Infant Formula Crisis Reveals About Food Safety Gaps

The recent recall of By Heart’s powdered infant formula (PIF) is a major food safety event—one that should prompt all stakeholders to pause and critically examine not just what happened, but what must improve going forward.

While recent FDA Warning Letters to major retailers are capturing headlines, the more important question is how this situation could have been prevented in the first place—so that a recall was never necessary at all?

The company has had prior food safety issues, and this event raises a legitimate debate: Was Clostridium botulinum in powdered infant formula a reasonably foreseeable hazard? What level of risk did or does it represent? And should this manufacturer and regulators have been proactively addressing it?

It"s important to distinguish between hazard and risk. A hazard is anything with the potential to cause harm; risk reflects the likelihood that hazard will be present combined with its severity.

A critical review of the scientific literature—including prior clinical cases linked to powdered infant formula, historical surveys demonstrating that neurotoxigenic clostridial spores can be  present in such products, and best practices already adopted by some manufacturers—suggests this hazard and risk was not merely hypothetical. The International Commission on Microbiological Specifications for Food (ICMSF), for example, has long concluded that screening raw materials for Sulfite Reducing Clostridia (SRCs) as a group of indicator organisms might be useful in assessing clostridial load and verifying adherence to Good Hygiene and Manufacturing Practices during the production of dehydrated dairy ingredients, including PIF.

Yes, hindsight is always 20/20, and a full root cause investigation will undoubtedly shed more light on how this event occurred. But seminal events like this must lead to serious inquiry, a challenge of long-held assumptions, and evolution as science and knowledge advance.

Recall Execution Matters—and This One Fell Short

The execution of the recall itself also revealed systemic weaknesses.

Initially, only two lot numbers were recalled—apparently with FDA approval. From the outset, many recognized the initial scope of the recall was too narrow. The recall was eventually expanded to include all lots, a foreseeable correction that should have been made from the beginning.

Rolling recalls that “creep” over time create confusion at the retail level, especially when stores receive multiple, evolving messages. Having worked in retail for over a decade, I can say with confidence that a single, properly bracketed recall would have been far more effective than one that unfolded in stages.

Further complicating matters, state regulators report that FDA did not convene a 50-state coordination call until well into the recall. That delay slowed what should have been an immediate, all-hands federal response during an exceptionally sensitive public health event.

Retail Failures—With Important Context

Recalled infant formula remaining on store shelves for weeks is UNACCEPTABLE. That said, it is important to distinguish optics from actual consumer risk.

For retailers with register-block capabilities, point-of-sale systems would have prevented consumers from completing a purchase. These systems lock out recalled items unless a manager overrides the alert. While seeing recalled product on shelves undermines public trust—and rightly so—the likelihood of a consumer leaving the store with recalled formula is lower when these systems are properly used.

Still, the presence of recalled product on shelves clearly signals a breakdown in retailers’ internal recall verification and effectiveness checks.

The Bigger Lesson: Prevention and Modernization

The bottom line is simple: prevention will always be better than a corrective action.

This event reinforces the urgent need to rethink food safety assumptions, strengthen preventive controls, and modernize how we track and manage products across the supply chain. Robust track-and-trace capabilities are essential—not just to identify where a product came from (trace-back), but to know quickly and with certainty where it was shipped and, ideally, where it is right now (trace-forward).

This crisis is also a real-world use case for item-level intelligence on powdered infant formula —technologies such as smart labels, RFID, or ambient IoT tags on each container. These tools would allow manufacturers, regulators, and retailers to instantly determine whether recalled products remain in stores or on shelves, dramatically improving recall speed, accuracy, and consumer protection.

We Can—and Must—Do Better

Parents, caregivers, and infants deserve no less.

It is time to modernize outbreak investigations, strengthen preventive food safety strategies, and deploy the technologies necessary to track, trace, and monitor foods with precision and confidence.

This outbreak and recall should be a turning point—not just a lesson learned, but a system improved.