1 Percent of the Formula Market, 48 Hospitalized Babies: What the ByHeart Recall Left Unanswered

A company that accounted for roughly one percent of the infant formula sold in the United States ended up, according to the Food and Drug Administration's own outbreak page, "disproportionately represented" among the babies hospitalized in the worst infant botulism outbreak the country has recorded. That gap, between how small a share of the market ByHeart Whole Nutrition Infant Formula held and how large a share of the sick infants drank it, is the first fact parents deserve to sit with. The second is what happened after regulators knew something was wrong: recalled cans stayed on store shelves in dozens of states for weeks, according to the FDA's own enforcement findings, while infants kept getting sick. This post lays out, with dates and sourcing, what is confirmed, what is still being investigated, and what families should do now. It is offered by the Law Offices of Elliott Owen Lipinsky as part of an ongoing effort to help families understand product safety recalls that reach their kitchens and their children.

The outbreak, in numbers

The CDC's final accounting of this outbreak, last updated in early March 2026, lists 48 total infant botulism cases connected to ByHeart formula, made up of 28 confirmed and 20 probable cases, across 17 states. Every one of the 48 infants was hospitalized. No deaths have been reported. The affected infants ranged in age from 16 to 264 days old. The investigation eventually reached back further than the initial outbreak period, documenting illness onset dates stretching from December 24, 2023 through November 29, 2025, after CDC retroactively reviewed older infant botulism cases once the ByHeart connection came into focus. All 48 infants were treated with BabyBIG, an intravenous medication made from immune globulin donated by adults immunized against botulism.

For comparison, the CDC's Dr. Jennifer Cope, chief of its Enteric Diseases Epidemiology Branch, has stated that the United States typically records only 150 to 180 cases of infant botulism nationwide in an entire year, across every possible cause. A single formula brand producing dozens of cases tied to one contamination event is, in the CDC's own characterization, unprecedented, the first outbreak of infant botulism ever formally linked to a commercial infant formula product.

An exact-date timeline of what regulators knew, and when

The FDA's own recall and outbreak pages, together with the CDC's investigation update, allow the sequence to be reconstructed with specificity.

On November 7, 2025, California's Department of Public Health, through its Infant Botulism Treatment and Prevention Program, alerted the CDC to a concerning cluster of infant botulism cases among infants who had consumed ByHeart formula. That same day, the FDA notified ByHeart it had identified an estimated 83 cases of infant botulism reported nationwide since August 2025, 13 of them in infants who had received ByHeart formula.

On November 8, 2025, ByHeart initiated a voluntary recall of two specific batches, coded 251261P2 and 251131P2, of its 24 ounce cans (UPC 5004496800), each carrying a "best by" date of December 1, 2026. The FDA issued a public warning the same day, and preliminary lab results from California's health department suggested the presence of Clostridium botulinum in an opened can fed to an infant with diagnosed botulism.

On November 11, 2025, the recall expanded to cover all lots and package formats of ByHeart Whole Nutrition Infant Formula nationwide, including the 24 ounce cans and the 0.60 ounce "Anywhere Pack" single-serve packets (UPC 5004496802, 14 packets to a package). By November 19, California's health department confirmed Clostridium botulinum Type A in an opened can, and the FDA's update at that point described 31 infants across 15 states with confirmed or suspected exposure, all hospitalized, none deceased. On November 20, ByHeart reported third-party testing had also found the bacteria in unopened samples. By November 26, 2025, the FDA recorded the last confirmed sighting of recalled formula on a retail shelf, following weeks of inspections.

On December 10, 2025, the CDC updated the case count to 51 hospitalized infants across 19 states, a figure that later narrowed as cases were formally confirmed or excluded, arriving at the final tally of 48 cases across 17 states. Two days later, the FDA sent formal warning letters to four major national retailers, discussed below.

By January 23, 2026, the FDA reported Clostridium botulinum had been identified in organic whole milk powder, an ingredient used in the formula, with genetic sequencing matching that bacteria to finished product samples and clinical isolates from sick infants. By March 5, 2026, the CDC had recorded no new cases since December 2025 and closed the outbreak investigation, noting the root cause work would continue. By June 3, 2026, the FDA reported it had completed on-site facility inspections and continued finding the bacteria in powdered milk ingredient samples, but stated plainly on its own outbreak page that it "has not yet determined a root cause."

Confirmed versus unconfirmed: a market-share gap and an open question

The FDA's own outbreak page states plainly that ByHeart represents an estimated one percent of all infant formula sold in the United States, yet the brand was, in the agency's words, "disproportionately represented among sick infants in this outbreak." That is a confirmed regulatory finding, not an inference drawn by this firm. What is not confirmed, as of the FDA's most recent public update in June 2026, is the precise mechanism by which Clostridium botulinum entered the supply chain. Investigators confirmed the bacteria's presence in an ingredient, organic whole milk powder, and matched its genetic profile to bacteria found in finished cans and in sick infants, a strong epidemiological link. That is not the same as a finished root-cause conclusion identifying exactly how, where, or at what point in production the contamination occurred, and regulators themselves have not yet closed that gap.

Why infant botulism is different from an ordinary foodborne illness

Infant botulism is not simply a stomach bug. The toxin produced by Clostridium botulinum attacks the nervous system. According to the CDC, early warning signs include poor feeding, constipation, a slowed pupil response to light, drooping eyelids, reduced facial expression, low muscle tone, a weakened cry, loss of head control, and difficulty swallowing. Left untreated, the toxin can progress to paralysis of the muscles used for breathing. That is why every one of the 48 infants in this outbreak was hospitalized and treated with BabyBIG, a specialized antitoxin that is not stocked at every hospital and often requires transfer to a facility equipped to administer it.

A recall is not the same as a product actually leaving the shelf

Perhaps the most troubling part of this record is not the contamination itself, which regulators say ByHeart voluntarily and cooperatively addressed once notified, but what happened after the recall was announced. The FDA's December 2025 enforcement findings, confirmed in its own warning letters and reported nationally, describe recalled ByHeart formula remaining available for purchase at major retail chains for weeks after the November 11 nationwide recall. FDA and state investigators conducted more than 4,000 retail compliance checks and still found recalled product on shelves in more than 175 store locations across 36 states before the last documented shelf sighting on November 26, 2025.

The FDA sent formal warning letters, dated December 12, 2025, to four major retailers: Target, Walmart, Albertsons, and Kroger. Target's recalled product was found in 20 states after the recall began, including one New Hampshire store that sold the formula on November 16 despite an electronic sales block, and an Arkansas store still advertising a two dollar discount on recalled single-serve packets between November 16 and 22. Walmart's product turned up in 21 states between November 12 and 26. Albertsons' product was found in 11 states between November 12 and 19, and Kroger's in 10 states over that window. FDA Commissioner Dr. Marty Makary said, "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." Each retailer was given 15 working days to document corrective action. This is not a story about a single manufacturer's failure. It is a story about a recall system that, by the federal government's own admission, did not work quickly enough to protect infants already being fed a product regulators had flagged as dangerous.

Families have already gone to federal court

By mid-December 2025, at least two families had filed federal lawsuits against ByHeart, according to national news reporting. One suit came from the parents of a four month old girl in Flagstaff, Arizona, who was hospitalized after her parents could not wake her, requiring nearly two weeks of care at a children's hospital before her recovery. A second came from the parents of a four month old girl in Richmond, Kentucky, who had been using ByHeart to supplement breastfeeding and was hospitalized after developing dilated pupils and a lost gag reflex. Both infants received BabyBIG and have since been discharged. Both lawsuits allege the formula was defective and that the company was negligent in how it was manufactured and sold. ByHeart has stated it remains focused on ensuring affected families are aware of the recall and has expressed sympathy for those involved. These filings are a matter of public federal court record, not speculation, and show the legal process addressing this outbreak is already underway in multiple states.

What Alabama parents should do right now

Alabama does not currently appear among the 17 states the CDC has listed in its confirmed case count for this outbreak. That is meaningful, but it is not a guarantee the recalled product never reached Alabama households. ByHeart formula was sold nationwide, online and through national retail chains that operate stores throughout Alabama, and the retail compliance failures documented by the FDA in dozens of other states raise a fair question about whether every recalled can and packet was actually pulled from shelves here.

Any parent or caregiver in Alabama who purchased ByHeart formula, in either the 24 ounce can or the Anywhere Pack singles, should stop using it immediately regardless of lot number, check it against the batch codes in the FDA's recall notices, and contact a pediatrician promptly if an infant who consumed it has shown any symptom described above, including poor feeding, weak crying, drooping eyelids, or loss of head control. Infant botulism can progress quickly, and early treatment with BabyBIG produces far better outcomes than delayed treatment. Do not wait for a symptom to become severe before seeking medical evaluation.

What should happen next

The FDA's own record leaves real questions open. The agency has not yet determined the root cause of how Clostridium botulinum entered ByHeart's supply chain, even after completing on-site facility inspections as of June 2026. Separately, the FDA has announced plans to test dairy-based ingredients such as milk powder and whey protein concentrate across the broader infant formula industry, with a deputy commissioner for human foods stating the goal is to determine whether botulism contamination represents "a foreseeable hazard" that formula makers should test for as a matter of course, not something discovered only after infants are hospitalized. That is reasonable, but it is a response to a crisis that had already sickened dozens of infants, not prevention taken before harm occurred.

Institutional accountability here has to run on two tracks. The manufacturer bears responsibility for what went into a product marketed to the most vulnerable consumers in the country, infants who cannot advocate for themselves. The retail supply chain that kept selling a federally recalled, potentially deadly product for weeks after being told to stop bears its own share, one the FDA itself has now documented in writing. Families deserve more than a corporate apology and a refund line. They deserve a supply chain that treats a recall notice as an immediate stop-sale order, not a suggestion implemented at a retailer's own pace.

Frequently asked questions

How many infants were affected, and how many died?

The CDC's final count, updated in early March 2026, lists 48 total infant botulism cases (28 confirmed, 20 probable) connected to ByHeart formula across 17 states. All 48 infants were hospitalized. No deaths have been reported.

What specific ByHeart products were recalled?

All lots and formats of ByHeart Whole Nutrition Infant Formula, including 24 ounce cans (UPC 5004496800) and 0.60 ounce Anywhere Pack single-serve packets (UPC 5004496802). The recall began November 8, 2025 with two batch codes, 251261P2 and 251131P2, and expanded November 11, 2025 to the entire product line nationwide.

Has the FDA determined how the formula became contaminated?

Not fully. As of the FDA's June 3, 2026 update, investigators had found Clostridium botulinum in organic whole milk powder used as an ingredient, genetically linked to samples from finished product and from sick infants, but the FDA states it has not yet determined a definitive root cause.

Why did recalled formula stay on store shelves after the recall was announced?

FDA warning letters dated December 12, 2025 found that four major retailers, Target, Walmart, Albertsons, and Kroger, continued to have recalled formula available in stores across dozens of states well after the November 11, 2025 nationwide recall, with product documented in more than 175 locations across 36 states before the last reported shelf sighting on November 26, 2025.

Was Alabama one of the affected states?

Alabama is not currently listed among the 17 states in the CDC's confirmed case count. However, ByHeart formula was distributed nationwide through retailers that operate in Alabama, and the documented delays in pulling recalled product from shelves elsewhere raise legitimate questions about complete removal here.

What should a parent do if their infant consumed recalled formula and is showing symptoms?

Stop using the product immediately and seek medical evaluation without delay for signs such as poor feeding, constipation, drooping eyelids, a weakened cry, loss of head control, or difficulty swallowing. Infant botulism is treated with BabyBIG, an intravenous antitoxin, and earlier treatment is associated with better outcomes.

Talk to a lawyer who will tell you the truth about your case

If your infant was hospitalized after consuming ByHeart formula, or any contaminated or defective infant product, you are entitled to real answers, not a form letter and a coupon. The Law Offices of Elliott Owen Lipinsky, based in Selma, Alabama, represents families across the state who have been harmed by defective and contaminated consumer products, including products marketed specifically to infants and young children. Call (334) 230-7986 to speak directly about your family's situation. There is no charge to discuss what happened, and no family should have to navigate a national recall and a sick infant without someone in their corner who will tell them plainly what the evidence shows.