As the number of infant botulism cases tied to ByHeart infant formula rises to 31 across 15 states, alarm is spreading among parents, health officials, and retailers nationwide. Despite a sweeping recall and urgent warnings from both the company and federal regulators, the potentially deadly formula has been found on store shelves as recently as mid-November 2025, prompting renewed scrutiny of recall enforcement and consumer safety practices.
ByHeart, a New York-based company that had been producing approximately 200,000 cans of formula per month, voluntarily recalled all batches of its Whole Nutrition Infant Formula cans and single-serve "Anywhere Pack" sticks after independent laboratory tests confirmed contamination with Clostridium botulinum. This bacterium, notorious for producing toxins that can cause paralysis and even death in infants, was detected in samples reported on November 19, 2025, as noted on ByHeart’s website and confirmed by the Associated Press.
The U.S. Food and Drug Administration (FDA) first announced the voluntary recall on November 8, 2025. Since then, the outbreak has grown, with cases reported in Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, according to USA TODAY and the FDA. The highest concentrations of cases have been seen in Oregon, California, Arizona, and Texas, as reported by the Centers for Disease Control and Prevention (CDC).
All 31 infants affected, ranging from just over two weeks old to about six months, have required hospitalization and treatment for infantile botulism since August 2025. The most recent case was reported on November 13. Thankfully, no deaths have been reported as of November 20, 2025, according to both the Associated Press and USA TODAY.
Despite the recall, the potentially contaminated formula has not been fully removed from circulation. Investigators in at least three states—Oregon, Minnesota, and Arizona—found ByHeart formula still for sale after the recall was announced. In Oregon, nine out of more than 150 stores checked still had the formula on shelves this week, a state agriculture official told the Associated Press. Minnesota investigators removed recalled products from four sites out of 119 checks conducted between November 13 and November 17, 2025. Arizona officials also confirmed the product’s continued availability, raising questions about the effectiveness of recall communication and enforcement.
Walmart, one of the primary retailers of ByHeart formula, responded by issuing a restriction to prevent further sales, removing the product from stores, and notifying consumers who had purchased it. Customers can return the formula to any Walmart store for a refund, with the product retailing at about $42 per can, as reported by the Associated Press.
ByHeart’s official statement underscored the company’s commitment to resolving the issue: "We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again." The company also notified the FDA of the contamination findings, although it did not specify the number of samples tested or how many tested positive.
The FDA has conducted inspections at ByHeart manufacturing plants in Allerton, Iowa, and Portland, Oregon, but has yet to release the results of these inspections. Meanwhile, California health officials confirmed the presence of the germ in an open can of ByHeart formula that was fed to a baby who later became ill.
Infant botulism is a rare but severe illness caused by Clostridium botulinum spores, which can germinate in a baby’s gut and produce a dangerous toxin. Symptoms can take up to 30 days to develop and may include constipation, poor feeding, a weak cry, drooping eyelids, a flat facial expression, and loss of head control. As the CDC warns, infants may also develop limb and head weakness, trouble swallowing, or breathing difficulties. The illness can be fatal if not treated promptly, making early detection and intervention critical.
Given the severity of the risk, both ByHeart and federal health officials have repeatedly urged parents and caregivers to cease all use of the recalled formula immediately. In a statement on Instagram, ByHeart emphasized: "We continue to urge parents and caregivers to stop using ByHeart formula immediately. Monitor your child for symptoms of infant botulism and seek medical care immediately if they develop symptoms." The CDC echoes this guidance, recommending that any remaining formula be clearly labeled "DO NOT USE" and stored for at least a month in case symptoms develop, so it can be tested if necessary.
Parents who purchased ByHeart formula from the company’s website are eligible for full refunds on up to two products, including both cans and Anywhere Packs. First-time customers can receive a full refund on their initial order. The FDA and CDC further advise that any surfaces that may have come into contact with the recalled formula be washed thoroughly with hot, soapy water or a dishwashing detergent to prevent further risk of exposure.
Federal and state health officials are especially concerned that some parents and caregivers may still have ByHeart products in their homes, unaware of the recall or the associated risks. To address the surge of inquiries, California’s health department launched a dedicated public hotline at 833-398-2022 on November 19, 2025. Staffed daily from 7 a.m. to 11 p.m. Pacific Standard Time, the hotline is intended to provide guidance and support to families who may be affected or have questions about the recall and infant botulism symptoms.
The recall and subsequent investigation have highlighted the challenges inherent in swiftly removing contaminated products from the market—especially those sold across a mix of online and brick-and-mortar channels. ByHeart formula was available nationwide, both online and at major retailers like Target and Walmart, making complete removal a logistical challenge. State officials and federal regulators continue to urge businesses and consumers to remain vigilant. As Minnesota officials put it bluntly: "No affected product should be sold or consumed."
As the situation continues to unfold, the focus remains on preventing further illnesses and ensuring that families are informed and protected. The hope is that the lessons learned from this outbreak will prompt stronger safeguards, swifter recall procedures, and better communication between manufacturers, regulators, retailers, and consumers—so that no family has to face this kind of fear again.
