ByHeart Recalls All Infant Formula Amid Growing Botulism Outbreak
ByHeart has expanded its recall to all infant formula products nationwide following an outbreak of infant botulism affecting 15 babies across 12 states.
ByHeart, a manufacturer of organic infant formula, has expanded its recall to include all products sold nationwide. This decision follows an outbreak of infant botulism that has affected 15 infants across 12 states since August. All affected infants were hospitalized after consuming ByHeart formula; no deaths have been reported.
The recall encompasses ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. Parents and caregivers are advised to immediately discontinue use and dispose of these products.
"This action underscores ByHeart’s core mission: protecting babies above all else," the company stated.
The U.S. Food and Drug Administration (FDA) is investigating 84 cases of infant botulism reported since August, with 15 cases linked to ByHeart formula. The FDA noted that ByHeart's products are disproportionately represented among the cases, considering the brand accounts for approximately 1% of U.S. infant formula sales.
Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria, which produce toxins in the immature intestines of infants. Symptoms include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, and breathing problems. Immediate medical attention is required for affected infants.
ByHeart produces its formula powder in Allerton, Iowa, and ships it to Portland, Oregon, for canning and distribution. FDA inspectors have been present at the Portland facility as part of the ongoing investigation.
In response to the outbreak, ByHeart is testing every batch of formula with an independent third-party laboratory, providing health officials full access to its facilities, and sharing results with regulators as they become available.
Parents and caregivers are urged to monitor infants who have consumed ByHeart formula for symptoms of botulism and seek immediate medical care if symptoms develop.