ByHeart Infant Formula Recall Triggers FDA Warning To Retailers

In a sweeping development that has rattled parents and retailers alike, the U.S. Food and Drug Administration (FDA) has issued stern warning letters to major retailers after a nationwide recall of ByHeart infant formula failed to prevent the product from remaining on store shelves weeks after the alert. The recall, prompted by a cluster of infant botulism cases linked to the formula, has shone a harsh spotlight on supply chain vulnerabilities, regulatory oversight, and the crucial responsibilities of both manufacturers and retailers in protecting the nation’s youngest and most vulnerable.

On November 11, 2025, ByHeart initiated a recall of all its infant formula products—cans and single-serve packs alike—after an investigation revealed an outbreak of infant botulism caused by the Clostridium botulinum bacteria. According to the FDA’s December 1 report, 51 cases of illness were identified across 19 states, affecting infants from just over two weeks to nearly nine months old. The illnesses, first reported in August and most recently in November, sent 23 infants in 13 states to the hospital, though, thankfully, no deaths have been reported so far, as detailed by Consumer Reports.

Despite the gravity of the recall, federal investigators found that ByHeart formula was still being sold in over 175 stores across 36 states, even after more than 4,000 inspections nationwide. The FDA’s warning letters, sent December 19 to Albertsons, Kroger, Target, and Walmart, described how the recalled formula lingered on store shelves for as long as three weeks in some cases. Target, in particular, was cited for having the formula in 20 states between November 12 and 20, with one store even advertising a $2 discount on the product after the recall began. Albertsons, Kroger, and Walmart were also found to have the formula available for sale in multiple states during the same period.

The FDA did not mince words in its public statement: “These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.” The agency emphasized that retailers represent the final checkpoint in the supply chain and must act swiftly to remove unsafe products. “The agency is particularly concerned with these retailers’ capability to quickly remove unsafe products from their store shelves and ensure it remains off shelves as required during a public health emergency,” the FDA stated.

Retailers have been given 15 days to respond to the FDA, outlining how they will address these violations and prevent future lapses. FDA Commissioner Marty Makary stressed, “Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food.”

For parents, the recall has triggered anxiety and a rush for information. ByHeart’s recall covers all lots and packages, with the FDA urging families to stop using the formula immediately. Parents are advised to document lot numbers, store the formula securely labeled “DO NOT USE,” and monitor infants for symptoms of botulism—constipation, poor feeding, loss of head control, weak cry, diminished facial expression, muscle weakness, and difficulty breathing. As Dr. Mona Amin, pediatrician and founder of Peds Doc Talk, told Consumer Reports, “The reassuring news is that almost all babies who do get infant botulism recover completely with prompt treatment. Staying informed and observant is the best thing parents can do.”

Infant botulism, while rare, can be fatal if untreated. The only treatment, an antitoxin known as BabyBIG, is produced exclusively by the California Department of Public Health. A spike in requests for the antitoxin, all linked to ByHeart formula, first alerted state health officials and the Centers for Disease Control and Prevention (CDC) to the outbreak. The FDA’s investigation is ongoing, with additional testing of both opened and unopened formula cans underway. Notably, ByHeart has maintained that “testing from a previously-opened can lacks scientific basis to establish causation between the product and illness,” and claims that no unopened cans have tested positive for C. botulinum so far.

Yet, the broader context is troubling. According to Consumer Reports, FDA inspections in January 2024 had already cited ByHeart’s Pennsylvania manufacturing facility for unsanitary conditions, contamination risks, and insufficient pest control. A prior warning letter in 2023 raised similar concerns after a 2022 recall for Cronobacter sakazakii. Brian Ronholm, head of food policy for Consumer Reports, remarked, “It’s very troubling that ByHeart appears to not have adequately addressed the FDA’s concerns over the serious problem involving unsanitary and contamination risk conditions at their plant.”

The presence of C. botulinum in powdered formula is rare, but experts warn that the spores are heat-resistant and can survive manufacturing processes. Dr. James E. Rogers, Consumer Reports’ director of product and food safety research, explained, “It is possible that the spores from C. botulinum came from contaminated ingredients or from the environment. And even if the product is heat-treated to kill or reduce the number of live bacteria, C. botulinum spores are heat-resistant and would survive the process.”

Adding to the confusion, current regulations do not require manufacturers to test for the botulism toxin in powdered infant formula. Devon Kuehn, ByHeart’s chief medical and scientific officer, stated, “Currently, global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum. We adhere to the rigorous safety and quality standards and have the utmost confidence in our product, in our safety systems, and in the people behind them.”

For families caught in the recall, the FDA and CDC recommend not only switching formulas immediately but also thoroughly washing or discarding bottles, nipples, and pacifiers that may have come into contact with the recalled product. Because C. botulinum spores are particularly resilient, some experts suggest replacing feeding items altogether if contamination is suspected.

Amidst the chaos, one silver lining is that ByHeart accounts for only about 1% of the national infant formula supply, and the FDA does not expect the recall to trigger a shortage. Still, many families are left scrambling for refunds. ByHeart has offered limited refunds for purchases made after October 1, 2025, but some parents have expressed frustration at the two-unit cap, especially when more formula was purchased in bulk. Retailers, on the other hand, are expected to provide full refunds for all recalled products, including opened cans, with proof of purchase and recall documentation.

The ByHeart recall serves as a sobering reminder of the stakes involved in food safety, particularly for infants. The ongoing investigation, regulatory scrutiny, and consumer outcry underscore the importance of transparency, accountability, and swift action when public health is at risk. As the FDA, CDC, and state officials continue their work, parents and caregivers are urged to stay vigilant, follow official guidance, and advocate for the highest standards of safety in the products they trust to nourish their children.