FDA Investigates ByHeart Baby Formula After 13 Infants Hospitalized

The U.S. Food and Drug Administration (FDA) has initiated a multistate investigation into ByHeart baby formula following reports that at least 13 infants have been hospitalized due to botulism. The affected infants consumed the formula between August and November 2023 across ten states, including Arizona, California, and Texas.

The FDA has issued a warning advising parents and caregivers not to feed babies specific lots of ByHeart Whole Nutrition Infant Formula. The affected lot numbers are 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of December 1, 2026. These numbers can be located on the bottom of the formula cans. In response to the situation, ByHeart has voluntarily recalled the products, which were sold both online and in major retail outlets nationwide.

Despite the recalls, the FDA has indicated that this formula represents less than 1% of all baby formula sold in the United States, alleviating concerns about potential shortages. The agency urges consumers to dispose of any remaining product from the specified lots and to mark the issue on the can.

“The last documented illness occurred in November,”

according to the FDA. Although no fatalities have been reported, the investigation is ongoing. Botulism is a rare but serious illness caused by a toxin that impacts the body’s nerves, leading to symptoms that can include difficulty breathing and muscle paralysis. In infants, signs of botulism may include constipation, poor feeding, and difficulty swallowing, which can escalate to respiratory arrest. Symptoms may take weeks to manifest after exposure to the toxin.

Health officials emphasize the importance of monitoring infants for these symptoms and recommend that anyone who notices these signs in their child should contact a healthcare provider immediately. The situation highlights the critical need for vigilance regarding infant nutrition and safety, as well as the swift action required when potential health threats arise.