FDA warns Walmart, Target and others as botulism outbreak tied to ByHeart formula expands, retailers still selling recalled product

WASHINGTON — The U.S. Food and Drug Administration issued warning letters to Walmart, Target, Albertsons Companies and the Kroger Co. after finding that major retailers continued to sell ByHeart infant formula recalled for contamination with botulinum-producing bacteria, despite public warnings and expanded recalls. The outbreak linked to ByHeart formula has sickened 51 babies across 19 states, with all affected infants needing hospitalization in neonatal intensive care units. Federal health officials have confirmed the presence of Clostridium botulinum in ByHeart samples, and specialists warn that botulism can progress rapidly in infants, leading to severe paralysis if not treated promptly.

Investigators also found that 175 store locations across 36 states still had the recalled product on shelves days or even weeks after stores were notified of the recall and after the recall was expanded. Target, Kroger and certain affiliated stores continued to sell recalled formula across multiple states, while Albertsons Companies reported sales in 11 states and Walmart across 21 states. In one noted instance, a Target store was found selling discounted “anywhere pack” sticks four days after the recall expansion was announced, a finding the FDA said showed not only a failure to remove recalled formula but also active promotion of the recalled product implicated in an infant botulism outbreak.

The health threat is particularly grave for infants. Botulism in babies occurs when Clostridium botulinum spores are ingested and germinate in an immature gut, producing a toxin that can paralyze muscles needed for feeding and breathing. Classic early signs include constipation, a poor suck, weak cry and diminished facial expressions, progressing to feeding difficulties, lethargy and respiratory compromise. Treatment with a botulism antitoxin, such as BabyBIG in the United States, is time-sensitive and can substantially improve outcomes. While adult botulism generally involves toxin already present in food, infant botulism results from spores that colonize the infant gut. To date, all illnesses linked to ByHeart have required hospitalization, but officials have not reported any deaths.

The recall timeline underscores the stakes. ByHeart initiated a limited recall on November 8, 2025, then expanded it to all batches of its Whole Nutrition formula on November 11 after regulators confirmed the outbreak's link to the product. Federal regulators have said that testing and epidemiological links identified the source, including botulinum spores found in opened cans from affected infants and later in sealed cans from store shelves. The FDA noted that persistent availability of recalled product on store shelves is a driving factor in the continued spread of illness and called on retailers to take prompt, comprehensive steps to remove affected lots from sale.

ByHeart has described its response as a company-wide audit of its supply chain. In statements to lawmakers and the public, the company said it is testing more product samples and working with independent laboratories to determine root causes and implement corrective actions, while continuing to support affected families. Health officials, meanwhile, emphasize that the outbreak remains under active investigation and that the priority is to prevent further exposure while ensuring impacted families receive care.

The FDA’s correspondence also signals potential civil action for noncompliance with recalls. The letters to Walmart, Target, Albertsons and Kroger warn that continuing to sell recalled products “may result in legal action, including, without limitation, seizure and injunction.” Investigators reported repeated attempts to discuss remediation plans with the retailers, but the firms did not respond publicly to the agency’s concerns, according to the letters.

Legal filings in three states portray a troubling pattern. In Arizona, Stephen and Yurany Dexter allege their infant daughter, identified as E.D. in court papers, developed botulism after being fed ByHeart formula and required hospitalization at Phoenix Children’s Hospital, later receiving a feeding tube and ongoing rehabilitation. A California case centers on infant A.B., born Sept. 29, 2025, who deteriorated within days of starting the formula and was treated at St. Joseph’s Medical Center with confirmed botulism and antitoxin therapy. A third suit, filed in Washington state, involves an Eatonville family whose infant developed botulism after consuming ByHeart formula and was hospitalized for several days. The plaintiffs describe dramatic declines in feeding, muscle strength and overall health, asserting that the formula contributed to the illness.

ByHeart has noted that the health and safety of babies remains its highest priority and has reiterated its commitment to transparency as regulators continue to investigate. In the broader public-health context, officials have described infant botulism as a rare but serious disease, with the CDC noting that about 150 to 180 cases are usually seen annually in the United States. The current cluster is being treated as unprecedented due to its scale and the ongoing involvement of multiple national retailers.

Public-health officials continue to urge parents and caregivers to stop using recalled ByHeart formula immediately and to seek prompt medical attention if an infant shows warning signs such as poor feeding, weak cry or breathing difficulty. Families who have used the product are advised to contact their pediatrician and to preserve any product and packaging for potential testing as the investigation proceeds. Regulators said they will continue to monitor the supply chain, enforce recalls and work with manufacturers to prevent a recurrence, aiming to protect infants while the investigation unfolds.