URGENT UPDATE: Federal health officials have confirmed that recalled baby formula linked to a serious botulism outbreak may still be available on store shelves across the United States. As of November 10, 2023, the Food and Drug Administration (FDA) reported 31 cases of suspected or confirmed infant botulism among babies who consumed ByHeart Whole Nutrition formula.
The troubling outbreak has affected infants in 15 states, including Arizona, California, and Kentucky. All affected babies have been hospitalized, although no fatalities have been reported. The illness can lead to potentially life-threatening paralysis in infants under one year of age, raising alarm among health officials and parents alike.
The FDA’s warning follows an intense investigation into ByHeart Whole Nutrition formula, which may be contaminated with Clostridium botulinum. The FDA indicated that despite the recall, it has received reports of the formula still being found on store shelves in multiple states, prompting an urgent call for consumers to check their supplies immediately.
ByHeart Whole Nutrition initially recalled two batches of its products earlier this month but expanded the recall to include all products last week. These formulas are sold at major retailers such as Target, Walmart, Publix, and Whole Foods, as well as online. Some products have even been shipped internationally.
In a statement, ByHeart emphasized its commitment to addressing the issue: “We are cooperating with the FDA and investigating every facet of our process to identify the cause of the outbreak.” The company has also set up a 24/7 support hotline for concerned parents and is offering refunds for purchases made since October.
Botulism is a rare but severe illness caused by the bacteria that can thrive in contaminated food. Symptoms, which can appear within 3 to 30 days after consuming the bacteria, include constipation, poor feeding, and loss of head control. Prompt medical attention is crucial, as untreated cases can lead to progressive paralysis and respiratory difficulties.
Parents are advised to monitor their infants for any concerning symptoms and to dispose of any remaining ByHeart formula, clearly labeling it “DO NOT USE.” The CDC has provided guidance on what families should do in response to the outbreak, including cleaning potentially contaminated surfaces and contacting health authorities if symptoms arise.
As the situation develops, the FDA is actively working with state partners and retailers to ensure an effective recall. The agency has also been closely monitoring the spread of botulism cases, which have risen since it first announced its investigation on November 8. At that time, a total of 83 cases of infant botulism had been reported nationwide, with 13 infants having consumed ByHeart formula.
The urgency of this situation is compounded by the fact that ByHeart’s products make up approximately 1% of the U.S. infant formula market, alleviating concerns about a nationwide shortage. However, the emotional toll on affected families is profound, with legal actions already initiated by parents of hospitalized infants, citing negligence on ByHeart’s part.
Stay tuned for more updates as this developing story unfolds. Parents are urged to remain vigilant and report any symptoms to healthcare providers immediately. For further information, refer to the hotline established by the California Department of Public Health specifically addressing this outbreak.
