Key Points:
- ByHeart Baby Formula: Two batches of baby formula recalled amid botulism probe.
- 13 Infants Hospitalized: Cases reported across 10 states since August 2025.
- No Toxins Found: Recall is precautionary; no confirmed contamination yet.
Baby nutrition company ByHeart has issued a voluntary recall of specific batches of its ByHeart Baby Formula (Whole Nutrition Infant Formula) after federal health authorities linked the product to a multi-state infant botulism investigation. The recall, announced on November 8, affects two production lots and involves less than 1% of total U.S. formula sales, according to the U.S. Food and Drug Administration (FDA).
The Centers for Disease Control and Prevention (CDC) reported 13 infant botulism cases across 10 states, all resulting in hospitalizations but no deaths. The affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Business Response and Recall Details
ByHeart, a New York–based startup focused on science-driven infant nutrition, said it launched the ByHeart Baby Formula recall “out of an abundance of caution,” emphasizing its commitment to safety and transparency. In a company statement, ByHeart clarified that no toxins have been detected in its formula but opted to remove the affected lots to protect consumers and maintain trust.
The recalled lots are identified as:
- Lot 206VABP/251261P2 with a “use by” date of Dec. 1, 2026
- Lot 206VABP/251131P2 with a “use by” date of Dec. 1, 2026
Both were manufactured in April and May 2025 and primarily distributed in July and August. Customers with affected cans are advised to dispose of the product immediately, and the company is offering free replacements for returned items.
The FDA confirmed that the product was distributed nationwide through both direct online sales and retail channels, but assured that the recall does not pose any shortage risks to the infant formula market. Testing of remaining product samples is ongoing, with results expected in the coming weeks.
Company Overview and Market Position
Founded in 2016, ByHeart has positioned ByHeart Baby Formula as a premium infant formula company that emphasizes clean-label ingredients, rigorous testing, and scientific innovation. The firm entered the competitive formula market in 2022 after receiving FDA approval, becoming the first new U.S. manufacturer to do so in over 15 years.
ByHeart operates its own vertically integrated supply chain, including manufacturing and quality control, to ensure product consistency and transparency—a core part of its brand identity. The recall, therefore, marks a significant operational test for the company’s quality assurance systems and customer relations strategy.
Industry analysts note that how ByHeart manages this recall could influence its brand reputation and investor confidence in the long term. While voluntary recalls can temporarily affect sales, proactive crisis management often mitigates consumer backlash and reinforces brand accountability in the baby nutrition sector.
Broader Market Context
The U.S. infant formula market has remained under scrutiny since the 2022 supply crisis, which highlighted vulnerabilities in production and safety oversight. Companies like ByHeart entered the market amid growing consumer demand for safe, traceable, and domestically produced formulas.
With less than 1% of its product affected, the recall is not expected to disrupt ByHeart’s overall operations or national formula supply. Still, it underscores the complex regulatory landscape that formula manufacturers must navigate, balancing innovation, compliance, and public trust.
As the FDA and CDC continue testing and investigations, ByHeart Baby Formula’s recall response may set a benchmark for crisis response in the infant nutrition industry.
