ByHeart, a once-trusted name in infant nutrition, is at the center of a nationwide health scare after announcing that all its baby formula products may be contaminated with Clostridium botulinum type A, the dangerous bacteria responsible for infant botulism. The revelation comes after laboratory tests linked dozens of illnesses to the company’s formula and forced a sweeping recall that has shaken parents, health officials, and the baby formula industry alike.
According to The Associated Press, ByHeart’s admission followed laboratory testing of 36 formula samples from three different lots. Alarmingly, five of those samples tested positive for the bacteria. The company posted a stark warning on its website: “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.” This marks a significant escalation from just two weeks prior, when ByHeart’s initial recall only affected specific batches and the company insisted that no unopened cans had tested positive.
Between August and late November 2025, at least 31 babies in 15 states were confirmed to have fallen ill with botulism after consuming ByHeart formula, federal and state health officials reported. Some infants had even been treated for botulism as early as November 2024—months before the current outbreak was officially recognized—though those earlier cases aren’t included in the official tally. The Georgia Sun highlighted that, of 84 infant botulism cases reported since August 2025, 36 babies had consumed infant formula, and more than a third of those cases involved ByHeart. This is especially striking given that ByHeart accounts for only about 1% of the U.S. baby formula market.
The symptoms of infant botulism are insidious and can take anywhere from 3 to 30 days to appear after exposure. Medical experts, cited by The Associated Press, warn that all infants under the age of one are at risk. The illness occurs when babies ingest spores that germinate in the intestine and produce a powerful toxin. Initial signs include constipation, which is often followed by difficulty sucking or feeding, a weak or altered cry, drooping eyelids, a flat or diminished facial expression, loss of head control, and overall lethargy. Weakness in the arms, legs, and head can also develop. Pediatricians stress that these symptoms constitute a medical emergency and require immediate treatment.
In response to the outbreak, ByHeart issued a nationwide recall of all its formula products on November 11, 2025. However, both state officials and the U.S. Food and Drug Administration (FDA) have confirmed that some recalled product remained on store shelves even after the recall was announced. The company has since expanded the recall to cover every can and Anywhere Pack of ByHeart formula, a move that underscores the seriousness of the situation. “This is a major change from two weeks ago,” The Georgia Sun reported, noting the company’s shift from targeted recalls to a blanket withdrawal of all products.
For parents and caregivers, the advice is unequivocal: stop feeding ByHeart formula to babies immediately and closely monitor children for symptoms of botulism. The company is offering full refunds for all purchases made on or after August 1, 2025—the date when the first baby in the outbreak became sick. Refunds can be requested by calling 866-201-9069, and, according to ByHeart, should arrive within five to seven business days. This policy marks an expansion from the company’s previous refund offer, which was limited to purchases made through its website.
The scale of the crisis is sobering. Since August 1, 2025, at least 107 babies nationwide have been treated for botulism with BabyBIG, an intravenous medication specifically designed for the illness. In a typical year, fewer than 200 infants are treated for botulism in the United States, making this outbreak especially alarming. The Associated Press noted that the number of affected babies treated in just a few months approaches the annual national average, underscoring the urgency of the recall and the need for vigilance among parents and healthcare providers.
Why did it take so long for the full extent of the contamination to come to light? According to experts, Clostridium botulinum type A can be unevenly distributed in powdered formula, meaning that not every can or scoop will necessarily contain the bacteria. This patchy distribution complicates testing and makes it difficult to identify the true scope of contamination until a large number of samples are examined. As The Associated Press explained, “Not all babies who ingest it will become ill, though all infants under age 1 are at risk.”
The FDA and state health departments are urging parents to report any illnesses potentially linked to the outbreak. Those who suspect their child may have been affected can contact an FDA consumer complaint coordinator or fill out an online MedWatch form. Meanwhile, pediatricians and hospitals across the country are on high alert for cases of infant botulism, ready to administer BabyBIG and provide supportive care.
For families who rely on formula to feed their infants, the ByHeart recall is a harsh reminder of the vulnerabilities in the supply chain and the critical importance of rigorous safety testing. While ByHeart’s swift move to expand its recall and refund policy has been welcomed by some, others are left wondering how such a widespread contamination could have occurred—and why it wasn’t caught sooner. The company’s initial assurances that no unopened cans were contaminated have now been proven wrong, raising questions about oversight and quality control in the industry.
As the investigation continues, parents across the country are left grappling with anxiety, uncertainty, and the urgent need to find safe alternatives for their babies. The hope is that heightened awareness, swift action, and transparent communication from both companies and regulators will help prevent similar crises in the future.
For now, the message is clear: if you have any ByHeart formula in your home, don’t take any chances. Stop using it, seek a refund, and watch for any signs of illness in your child. With vigilance and prompt medical care, the risks of this rare but serious illness can be minimized, even in the face of such an unsettling outbreak.
