On Dec. 10, 2025, the FDA announced that, as a result of the ongoing investigations into the contamination of ByHeart infant formula, the Centers for Disease Control expanded the case definition to include any infant diagnosed with botulism who was exposed to ByHeart formula since the product was released in March 2022. This expanded definition resulted in the addition of 10 new cases, bringing the total to 51 infants from 19 states. The FDA indicated that neither the Agency nor ByHeart can rule out contamination of all ByHeart formula at this stage of the investigation, and the source of contamination remains unknown.
On Nov. 8, 2025, the FDA, in collaboration with the California Department of Health’s Infant Botulism Treatment and Prevent Program, announced an investigation into a multistate outbreak of botulism. At that time, ByHeart formula was found to be associated with all the investigated incidents, and ByHeart initiated a recall of two lots of the product. The recall was subsequently expanded to include all lots of ByHeart formula on Nov. 11, 2025.
In an unusual move, the FDA released three Establishment Inspection Reports (EIRs) for the ByHeart formula manufacturing facilities (ByHeart is the parent company of three Blendhouse manufacturing facilities). Historically, EIRs were not typically available absent a Freedom of Information Act (FOIA) request. The EIRs are detailed and provide extensive detail on the sites and FDA’s impressions of the operations. In the case of the Blendhouse Allerton site, the EIR includes a discussion on numerous issues around rodent activity and potential contamination of raw ingredients, rust and stains on the floors of the production areas, and unclear procedures relating to the environmental monitoring program. The inspection resulted in the issuance of an FDA Form 483 with three observations, two “Additional Observations” and seven management discussion items. Similarly, the inspection of the Blendhouse Portland site resulted in a Form 483, but most striking was the EIR discussion of multiple customer complaint examples, including seven that include infants diagnosed with Salmonella(ByHeart’s investigations found no evidence that the formula caused the infection). The release of such information places manufacturers in a difficult position, as the EIR represents the FDA’s review but does not include any insight from the manufacturer. Taken out of context, these inspectional documents can paint a dark picture of a complex manufacturing process, providing fodder for potential litigants.
Implications of Expanded Case Definitions
The FDA’s expansion of the case definition to include all lots of formula produced by ByHeart is significant. Investigating potential contamination that extends across production sites is always complicated, and when the target population is a vulnerable group such as infants, the implications of that investigation are amplified. Having a robust manufacturing program that is compliant with current good manufacturing practices is essential and required under 21 CFR §106.5. Recalls such as this one reaffirm the need for strict manufacturing controls, including oversight over suppliers, controls to prevent adulteration, facility maintenance, and internal audit and investigation programs. Importantly, 21 CFR §106.55, which regulates the controls to prevent adulteration from microorganisms, lists only Cronobacter spp. and Salmonella spp. as microorganisms for which testing is required. If a recall involves a different pathogen, there will likely be no documented acceptance criteria to narrow the scope of the recall. Without a documented contamination source or a detailed history of release testing for that pathogen, the FDA is likely to broaden the recall, increasing the recalling firm’s revenue loss and heightening the risk of an infant formula shortage.
Potential Implications of Increased FDA Transparency
The publication of the EIRs align with a broader FDA transparency initiative that includes public release of drug complete response letters (CRLs). Earlier this year, the FDA launched a public CRL database and in September 2025 added a second batch of 89 CRLs tied to pending or withdrawn new drug applications or biologics license applications. Historically, these materials were closely held and obtainable only through FOIA, if at all. The FDA indicated it intends to publish additional previously issued CRLs and to post future CRLs promptly after issuance. Although these CRLs concern drug and biologic applications, the trend signals that the FDA is willing to surface unfavorable regulatory records that show deficiencies and corrective expectations, reducing participants’ control over their narrative. Applied to infant formula operations, that same emphasis on visibility makes inspections and EIR narratives more accessible to the public.
- Amplified Litigation Exposure. Public release of EIRs that catalog specific facility deficiencies increase litigation risk across multiple fronts. Plaintiffs’ lawyers can treat the EIR as a roadmap to plead negligence, failure-to-warn, consumer protection, and breach of warranty claims, and to defeat early motions by citing the FDA’s factual findings about conditions and corrective actions. Consumer class actions are likely, but retailers may be drawn in by downstream suits and then seek contractual indemnity or assert breach and merchantability claims against ByHeart. Beyond private litigation, the Department of Justice, state attorneys general and local public health authorities may scrutinize the same record to evaluate enforcement theories, particularly if the EIR suggests extended compliance gaps or product distributed during periods of alleged nonconformance.
- Amplified Political Scrutiny. The FDA’s decision to allow production to continue at certain facilities while shutting down others after a warning letter, such as the Blendhouse Reading facility, invites political pressure, especially in light of the 2022 infant formula crisis and national sensitivity to supply disruptions for such a sensitive population. Congress historically convened hearings with regulatory agencies to investigate how major recalls were allowed to occur, demanded timelines and corrective action plans from the FDA and manufacturers, and floated statutory reforms when formula availability was threatened. Similar scrutiny could come from state officials who manage WIC participation, or from governors and attorneys general in states where facilities operate.
Practical Implications for Industry Players
On Dec. 15, 2025, the FDA reminded the food industry of its recall obligations under federal law and urged adoption of best practices, issuing warning letters to major retailers after inspections found recalled ByHeart infant formula still on shelves in more than 175 locations across 36 states and requiring responses within 15 days. These actions, taken amid a multistate infant botulism outbreak tied to ByHeart formula, build on broader efforts to strengthen recall communications and effectiveness.
The current regulatory environment has been challenging for manufacturers to navigate. The push for greater transparency has lifted the veil of confidentiality on inspections and negative interactions with regulatory agencies such as the FDA, creating a new front for potential litigation and enforcement action. Against this backdrop, firms operating in the infant formula space should stress-test compliance programs under 21 CFR Part 106, rigorously document environmental monitoring and supplier controls, and prepare for inquiries that look beyond Cronobacter and Salmonella to other pathogens, such as botulinum species, for which testing standards may be less defined. Best practices include near-term planning for escalated regulatory engagement, litigation preparedness and communications strategies calibrated to a more transparent FDA environment and a sensitive infant nutrition market.
McGuireWoods continues to monitor the FDA’s investigation into the outbreak. For further information on the investigation and its potential implications, contact the authors.