Federal and state health agencies are investigating 13 confirmed cases of infant botulism across 10 U.S. states, all reportedly linked to recalled batches of ByHeart Whole Nutrition Infant Formula. The affected infants, who were hospitalized, had consumed products from two specific lots under recall, according to the U.S. Food and Drug Administration (FDA).
Formula Recall and Investigation
ByHeart Inc., a U.S.-based baby formula manufacturer, initiated a voluntary recall of two production lots—206VABP/251261P2 and 206VABP/251131P2—following reports of botulism infections. The FDA said Saturday that it is conducting a joint investigation with the Centers for Disease Control and Prevention (CDC) to determine the source and extent of the contamination.
No deaths have been reported. Officials emphasized that the recall is a precautionary measure as they assess whether any other batches were affected. The company’s products, available both online and through major retailers, represent roughly 1% of the national baby formula market, according to the CDC.
States Reporting Cases
The 13 confirmed cases have been identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All affected infants were hospitalized, but health officials have not disclosed further medical details.
Public Health Advisory
Authorities urged parents and caregivers who purchased ByHeart formula to immediately check the product lot numbers before discarding or returning any containers. The CDC advised consumers to record the lot number for reference and clean any bottles, utensils, or surfaces that came into contact with the recalled formula using a dishwasher or hot, soapy water.
The CDC also warned that symptoms of infant botulism can take several weeks to appear. Parents should seek medical attention immediately if their child shows signs such as poor feeding, weak crying, loss of head control, difficulty swallowing, or reduced facial expression.
Understanding Infant Botulism
Infant botulism is a rare but serious condition caused by Clostridium botulinum bacteria, which produce toxins in the intestines that can affect the nervous system. According to the CDC, it is most common in babies under one year old, particularly those between two and six months.
While most infants recover fully with prompt medical treatment, the illness can cause severe muscle weakness and breathing difficulties if untreated. The bacteria responsible for botulism are naturally found in soil and dust and can contaminate food or formula under certain conditions.
Ongoing Federal Oversight
The FDA said it is reviewing ByHeart’s manufacturing processes and supply chain records to determine how the contamination occurred. The agency’s investigation will also assess whether current food safety protocols for powdered infant formula were followed and if further actions are needed to prevent future incidents.
ByHeart, which markets its Whole Nutrition Infant Formula as made with organic ingredients and designed for sensitive digestion, has not yet issued a public statement beyond confirming cooperation with federal authorities.
Health experts note that the incident highlights ongoing safety concerns in the U.S. infant formula industry, which has faced heightened regulatory scrutiny since a major formula recall in 2022 led to nationwide shortages.
Consumer Safety Measures
The FDA and CDC reiterated that consumers should only use formula from verified safe batches and avoid feeding any recalled products to infants. Parents uncertain about formula safety can contact their pediatrician or report concerns directly to the FDA’s consumer complaint system.
The agencies are expected to release additional updates as testing and traceability efforts continue in the coming weeks.
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