Infant botulism cases have surged to 37 amidst an outbreak that has been linked to ByHeart baby formula, according to reports. The Food and Drug Administration (FDA), responsible for regulating and overseeing pharmaceutical products in the United States, has issued warnings that the products are still being circulated in stores despite an active recall.
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The FDA disclosed in a press release dated Wednesday, November 26, that they are observing a multi-state outbreak of infant botulism, directly associated with ByHeart Whole Nutrition Infant Formula. This unfortunate situation has resulted in 37 infants being hospitalised due to the ingestion of the contaminated formula. The illnesses initially appeared on August 9 and have since spread to affect 17 states.

As of now, there have been no reported deaths connected to this outbreak. ByHeart has not responded to requests for comments from PEOPLE at this time. Mia Funt, co-founder and president of ByHeart, expressed in a statement on November 11 that the welfare and safety of every infant using their formula is their utmost priority. She acknowledged the nationwide recall initiated by the company and vowed to collaborate with authorities to ascertain the cause of the widespread outbreak.
The FDA has provided details that the recalled formula is still available for purchase on the shelves of various retail stores across multiple states, such as Walmart, Target, Kroger, Sprouts Organic Market, Safeway, Acme, Jewel-Osco, Albertson’s, Whole Foods, Wegman’s, and Publix, among others. The public is advised that all ByHeart infant formula products have been recalled and should not be consumed or sold either online or in physical stores. This caution extends to all types of packaging, including formula cans and single-serve ‘anywhere pack’ sticks.
ByHeart, a self-proclaimed ‘next-generation baby nutrition company,’ has taken action to remove all their products from the market as they collaborate with the FDA in identifying the root cause of the outbreak. While botulism is rare, it is considered a severe condition. The company has shared common symptoms to watch out for in infants, including constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty swallowing, weak cry, general weakness, and possible respiratory issues leading to respiratory arrest, amongst others.
If parents have purchased this formula, they are strongly advised to discontinue use immediately and dispose of the product appropriately. Moreover, caregivers should seek medical attention promptly if their child displays any of the mentioned symptoms. Individuals with concerns or inquiries can reach out to ByHeart via email at [email protected], or by calling 1 (833) 429 – 4327 for assistance.
It is essential for parents and caregivers to be vigilant and aware of the signs of infant botulism, especially during this recall period. The health and well-being of infants should always be the top priority, and taking proactive measures in such situations can prevent further complications and safeguard children’s health. Stay informed and updated regarding this developing situation to ensure the safety of infants everywhere.
