The FDA’s latest action signals a broader shift in how federal regulators are approaching food safety in one of the country’s most sensitive product categories. On July 13, the agency narrowed that message to infant formula, telling the entire supply chain that recent contamination events exposed weaknesses far beyond any single brand. For families who buy formula through major retailers and online platforms across the U.S., the notice underscores how ingredient sourcing and supplier oversight have become central food safety issues.
FDA’s warning reached far beyond one manufacturer
The U.S. Food and Drug Administration said on July 13 that it sent a formal letter to manufacturers, packagers, distributors, exporters, importers, and retailers involved in infant formula and formula ingredients, according to the agency’s constituent update and the text of the letter itself. FDA said the step followed two multistate infant botulism outbreaks linked to powdered infant formula brands ByHeart and Nara Organics, both of which resulted in voluntary recalls. The letter also cited a separate contamination event involving arachidonic acid, or ARA, oil used in infant formula.
FDA said the ByHeart outbreak was the first botulism outbreak definitively tied to infant formula in the United States since infant botulism was first described as a distinct condition nearly 50 years ago. In its outbreak records, FDA said the ByHeart investigation ultimately involved 48 illnesses, including 28 confirmed and 20 probable cases, across 17 states, with 48 hospitalizations and no deaths. The agency said its investigation remains focused on supply-chain and ingredient pathways.
The agency also pointed to the June 13, 2026, Nara Organics recall. FDA said Nara voluntarily recalled all lots of its powdered infant formula after officials reported three infant botulism cases in California, Washington, and Pennsylvania involving infants who had consumed the product. FDA’s public recall notice said all three infants were hospitalized and no deaths were reported.
What the notice means across the U.S. retail market
The FDA’s letter was national in scope, and that matters because both formula brands reached consumers through broad retail and e-commerce channels. FDA said Nara Organics Powdered Infant Formula was distributed nationally through Target stores, Target.com, and Nara.com between July 2025 and June 2026. The recall covered Nara Organics Whole Milk Infant Formula in 700-gram and 400-gram cans, and FDA published the affected UPCs and lot codes in its recall notice.
For ByHeart, FDA said product distribution was nationwide, including Guam and Puerto Rico, as well as international markets. The agency’s case-count map lists illnesses in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin. FDA has not released a new state-by-state breakdown tied specifically to the July 13 industry letter, because the letter addressed the supply chain broadly rather than a newly announced consumer recall.
What is not yet known is whether any additional retailers or ingredient suppliers will face public enforcement steps tied to the latest warning. The July 13 letter does not name new stores, warehouses, or state-specific retail actions. Instead, it puts every company handling infant formula or its ingredients on notice that FDA expects closer monitoring of recalls, outbreak investigations, and import alerts.
Why FDA says the whole supply chain is now responsible
FDA tied the warning directly to ingredient risk and supplier oversight. In the July 13 letter, the agency said the ByHeart and Nara events appeared to share a supply-chain thread: Organic West Milk supplied dairy ingredients connected to both companies, and FDA confirmed that samples of organic whole milk powder matched outbreak-related findings in the ByHeart investigation. The agency said its root-cause work is ongoing and has not yet reached a final determination for every pathway involved.
The letter also referenced a separate international contamination event from late 2025 through early 2026 involving nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries. FDA said that event was traced to contaminated ARA oil used as an infant formula ingredient, prompting recalls and leading to CABIO Biotech ARA oil products being placed on FDA Import Alert 99-51 on May 12, 2026. The agency said those incidents show how hazards can enter formula through ingredients before manufacturing is complete.
For customers, the practical takeaway is that FDA is not announcing a new nationwide formula recall with this letter. Instead, the agency said companies are expected to verify suppliers, quarantine ingredients that fail specifications, review safety signals quickly, and act swiftly when concerns emerge. FDA said it will continue using its available tools to protect infants while pressing the industry to strengthen oversight at every stage of production and distribution.