Formula recalled in connection with multi-state infant botulism outbreak

A baby nutrition company has voluntarily recalled two batches of formula amid an ongoing investigation into an infant botulism outbreak.

ByHeart recalled two batches of ByHeart Whole Nutrition Infant Formula, which is sold online and at major retailers nationwide.

One has a batch code of 251261P2, and the other has a batch code of 251131P2. Both products have a UPC of 5004496800 and a use-by date of 01 Dec 2026.

The FDA and CDC are investigating a multi-state outbreak of 13 infant botulism cases between August and November, including one in Pennsylvania. All of the cases included in the outbreak consumed the ByHeart formula at some point. No deaths have been reported at this time.

According to the CDC, infant botulism is a rare but serious illness that happens when spores of the bacterium Clostridium botulinum or related species are swallowed. These spores then colonize in the large intestine and produce neurotoxins.

Symptoms of infant botulism include constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, diminished suck and gag reflexes, weak and altered cry, and respiratory difficulty and possibly respiratory arrest.

While the FDA says testing of the formula is still underway and results aren’t yet available, ByHeart Co-Founder and President Mia Funt says no testing has confirmed the presence of Clostridium botulinum spores or toxin in any of the company’s products.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” Funt said. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents.”

Anyone who has the recalled formula should discontinue use and throw the product away immediately. ByHeart will replace discarded formula at no cost. Anyone with questions can contact the company by calling 833-429-4327 or emailing hello@byheart.com.

The FDA does not expect this recall to create a shortage concern, since the formula makes up less than 1% of infant formula sold in the United States.

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