Recalled ByHeart infant formula continues to circulate in stores despite an FDA recall announced in November, raising fresh concerns for parents who may unknowingly purchase formula linked to 28 confirmed cases of infant botulism. The U.S. Food and Drug Administration (FDA) ordered a voluntary recall of all batches of ByHeart Whole Nutrition Infant Formula after a multistate investigation connected the product to a rare but potentially fatal bacterial illness. Months later, regulators say recalled cans and packets remain in circulation, particularly at discount, salvage, outlet, and surplus retailers where expired or recalled goods sometimes re-enter the supply chain.

Why Is Recalled Formula Still Being Sold?

One significant reason recalled ByHeart formula continues to surface is its long shelf life. Some recalled batches carry use-by dates as late as December 1, 2026, meaning they may still appear "in date" long after the recall was announced. This creates a dangerous situation where parents shopping at non-traditional retailers may believe a product is safe simply because the expiration date hasn't passed.

Health officials stress an important distinction: expiration dates do not override recalls. Once a product is recalled, it is unsafe to use regardless of how far away the printed date may be. The South Carolina Department of Agriculture (SCDA) issued a renewed alert after the FDA confirmed recalled products were still being found on shelves, urging any retailer or distributor that finds recalled ByHeart formula to immediately remove and destroy it.

What Health Risks Does Infant Botulism Pose?

Infant botulism occurs when babies ingest spores of Clostridium botulinum, a bacterium that can grow in the intestines and release toxins. The condition is rare but potentially life-threatening. According to the Centers for Disease Control and Prevention (CDC), symptoms can include constipation, poor feeding, weak crying, low muscle tone, difficulty breathing, and in severe cases, respiratory failure.

A critical concern is that symptoms may take weeks to develop, making vigilance essential even after exposure ends. The CDC reiterated in a February message that parents should not use the recalled formula and should monitor their children closely if they have consumed it, even if symptoms haven't appeared yet.

Steps to Protect Your Baby When Buying and Preparing Formula

• Check Product Details Before Purchase: The FDA advises caregivers to verify the brand name, product description, and recall status, not just the expiration date, before feeding any infant formula. This is especially important when shopping at non-traditional retailers.
• Use Safe Water for Preparation: Distilled or purified water is a safe and commonly recommended option because it removes contaminants such as lead and nitrates while still allowing the formula to provide all necessary nutrients. Tap water can also be safe if it comes from a regulated municipal supply with no lead or contamination concerns, but experts caution against using hot tap water, which can leach metals from pipes.
• Clean Formula-Making Equipment Thoroughly: If you used recalled ByHeart formula in a Baby Brezza or other automatic formula maker, thoroughly clean and descale the equipment before putting new formula into the machine. This helps ensure bacteria isn't still present in the machine, which could contaminate safe formula.
• Monitor for Delayed Symptoms: If a child has consumed recalled formula and is experiencing symptoms of botulism, seek medical attention immediately. If the child isn't experiencing symptoms, continue monitoring them because symptoms can take several weeks to develop.

The recall covers all batches of ByHeart Whole Nutrition Infant Formula, including 24-ounce cans and single-serve Anywhere Pack packets, regardless of lot number or expiration date. Federal investigators linked the product to 28 confirmed cases and 20 probable cases of infant botulism nationwide.

Although no new cases have been added since December 2025, investigations are still ongoing into how the bacteria entered the product. The FDA told anyone who finds the recalled formula in a store to contact their local office. Parents who discover recalled formula in their home should throw it away immediately.

For parents preparing formula, water choice matters significantly, particularly for infants who consume large volumes relative to their body weight. Some pediatricians recommend boiling tap water and letting it cool before mixing it with formula when babies are newborns as a way of killing potential bacteria and parasites that could be harmful to newborns and babies who are immunocompromised. Parents with questions about fluoride exposure or local water safety are encouraged to consult pediatricians or review local water quality reports.