ByHeart, a company specializing in baby nutrition, has voluntarily recalled two batches of its Whole Nutrition Infant Formula. The decision follows notification from the U.S. Food and Drug Administration (FDA) about an ongoing investigation into a recent outbreak of infant botulism across the United States.
Infant botulism is a rare but serious illness caused by Clostridium botulinum spores, which can colonize an infant’s intestinal tract and produce harmful neurotoxins. Symptoms include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and potentially respiratory arrest.
The FDA is currently investigating multiple cases of infant botulism among babies nationwide. Since August 2025, approximately 83 cases have been reported. Of those cases, 13 infants had received ByHeart formula at some point. However, the FDA has not found any direct link between infant formula—including ByHeart products—and these cases of botulism. Historically, there has been no precedent for infant formula causing this illness; botulism more commonly originates from environmental sources such as soil and certain vegetables.
ByHeart stated that it maintains strict standards for product testing and safety in line with global and U.S. guidelines. According to the company’s announcement: “The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, Co-Founder and President. “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. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
The recall affects only two specific batches: batch code 251261P2 (use by December 1, 2026) and batch code 251131P2 (use by December 1, 2026), both with UPC code 5004496800. The batch codes can be found on the bottom of each can.
No other batches are impacted by this recall.
Consumers who purchased formula from these batches should stop using it immediately and dispose of any remaining product. ByHeart will replace discarded cans at no cost to customers.
Parents whose infants show symptoms associated with infant botulism are advised to contact healthcare providers promptly.
For questions or additional information about this recall or replacement cans, consumers can contact ByHeart’s support team at 1 (833) 429-4327 at any time.
