The US Food and Drug Administration (FDA) has issued stern legal warnings to several major retailers, including Walmart and Target, after discovering they continued to sell recalled infant formula linked to a deadly toxin. This comes amid a rapidly escalating outbreak of infant botulism that has seen dozens of babies hospitalised across multiple states.
Unprecedented Outbreak and Failed Recalls
Government health officials have described the outbreak of botulism in babies who consumed the formula as 'unprecedented'. To date, 51 infants across 19 states have fallen ill, requiring treatment in neonatal intensive care units. The source was traced to ByHeart infant formula products contaminated with Clostridium botulinum bacteria, which produce dangerous toxins in a baby's gut.
Despite an initial limited recall by ByHeart on 8 November 2025, and an expanded recall covering all batches of its Whole Nutrition formula on 11 November, the FDA found that major retailers failed to remove the product from shelves. The agency sent warning letters to Walmart, Target, Albertsons Companies Incorporated, and the Kroger Company, stating that continued sales 'may result in legal action, including seizure and injunction.'
FDA investigators confirmed that 175 locations across 36 states still had the recalled formula available days and even weeks after the recall was initiated. In one alarming instance, a Target store was found selling discounted 'anywhere pack' sticks of the formula four days after the recall announcement.
Severe Health Consequences for Infants
Infant botulism is a life-threatening disease that causes progressive muscle paralysis. Symptoms in affected babies include feeding trouble, difficulty holding up their head, weak crying, decreased facial expressions, and general muscle weakness. The Centers for Disease Control and Prevention (CDC) has urged parents to stop using the formula immediately.
Dr Jennifer Cope of the CDC noted that while 150-180 individual cases of infant botulism are typically seen annually, a full-blown outbreak is unprecedented. The outbreak was confirmed through epidemiological links and laboratory testing, which found Clostridium botulinum spores in both opened cans from sick infants and in sealed cans from store shelves.
Recovery from the illness can take weeks and often involves extensive rehabilitation, with some children experiencing breathing difficulties for years afterwards.
Legal Actions and Family Heartbreak
Federal lawsuits filed in Arizona, California, and Washington state detail harrowing accounts from families whose previously healthy infants suffered sudden, severe neurological decline after consuming ByHeart formula.
One lawsuit involves an Arizona couple, Stephen and Yurany Dexter, whose daughter, E.D., began showing symptoms in late August 2025. Within a week, she could no longer suck, swallow, or hold up her head. She was hospitalised, treated with an antitoxin, and discharged with a feeding tube, continuing to face ongoing health challenges.
Another case in California centres on infant A.B., who deteriorated rapidly after a healthy check-up in October. He was admitted to a neonatal ICU, unable to latch or hold up his head. His parents stated the ordeal 'shattered the trust' they placed in the company.
A third lawsuit from Washington state describes similar severe symptoms in an infant daughter, including choking and extreme fatigue, leading to hospitalisation.
In a statement, ByHeart said it recognised the news was 'heartbreaking for parents' and was committed to working with 'speed and transparency' to find the root cause. The FDA has criticised the retailers for their lack of response to repeated requests to discuss plans to remedy the ongoing sale of the recalled products. All affected babies have been hospitalised, but no deaths have been reported.
