Botulism outbreak sickens more than 50 babies and expands to all ByHeart products

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By JONEL ALECCIA, Associated Press

Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.

The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.

The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.

No deaths have been reported in the outbreak, which was announced Nov. 8.

Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.

ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.

News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”

“That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”

ByHeart officials did not immediately respond to questions about the expanded outbreak.

Lab tests detected contamination

The FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.

The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.

Inspection documents showed that ByHeart had a history of problems with contamination.

In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”

A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, inspection documents show.

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Infant botulism is rare

Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.

Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.

Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.

The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.

The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.

“The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.

Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

New Richmond: 8-year-old dies in crash on icy curve

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An 8-year-old boy died from injuries sustained in a two-vehicle crash Tuesday morning in the 1500 block of County Road A in Richmond Township, Wis.

A 2004 Chrysler Pacifica, which had been traveling southbound, lost control on an icy curve and hit a 2018 Suburu Outback that was traveling northbound, according to the St. Croix County Sheriff’s office.

The driver of the Chrysler was identified as Alisha M. Hailey, 27, from New Richmond, Wis. Her passenger, Owen P. Hailey, 8, was seated in the third row of the van. Owen suffered critical injuries and life saving measures were performed. He was taken to Westfields Hospital in New Richmond and then by ambulance to Regions Hospital in St. Paul, where he died later that evening. Alisha Hailey sustained serious injuries and was treated at Regions. Both wore seatbelts at the time of the crash.

The driver of the Suburu was Linda D. Stefonek, 71, of New Richmond. She was treated for minor injuries at the scene and released. She wore a seatbelt at the time of the crash.

The New Richmond Youth Hockey Association posted on Facebook news of the accident and asked the community to “put their sticks out and leave a light on for one of our own.”

“Owen was a 4th year Mite in our association and a wonderful friend to so many in our hockey family. We as a hockey family mourn the loss of Owen, but we stand committed to being there to support his family,” the post read.

This incident represents the 10th traffic fatality recorded by St. Croix County in 2025.

This crash remains under investigation.

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IOC president Coventry sets early 2026 target for new Olympic policy on gender eligibility

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By GRAHAM DUNBAR, Associated Press

GENEVA (AP) — The IOC set a target Wednesday of early 2026 to detail a new policy on eligibility in female sports that could see transgender athletes excluded from the Olympic Games.

International Olympic Committee president Kirsty Coventry also stressed the Olympic body’s statutory belief in access to sport being a human right for all people at grassroots and recreational level.

The two-time Olympic champion swimmer created a working group after taking office in June to review “protecting the female category.”

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Coventry won an IOC presidential election where most of the seven candidates promised a stronger policy on gender eligibility. Previously, the IOC only offered guidance to the individual sports’ governing bodies, who were left to decide on their on rules.

“I am really hopeful that in the next couple of months, and definitely within the first quarter of next year, that we will have a very clear decision and way forward,” Coventry said at a news conference after a meeting of the executive board she chairs.

That timetable could see an IOC policy — likely on transgender athletes and athletes with differences on sexual development (DSD) — confirmed at its meeting on the eve of the Milan Cortina Winter Games that open Feb. 6.

The 2028 Summer Games follows in Los Angeles, and President Donald Trump signed an executive order in February, “Keeping Men Out of Women’s Sports,” that could stop funding for organizations which let transgender athletes compete in women’s and girl’s sports.

The U.S. Olympic and Paralympic Committee in July effectively barred transgender women from competitions, telling its national federations in Olympic sports they had an “obligation to comply” with the government order.

World governing bodies in top-tier Olympic sports track and field and swimming had already banned athletes who went through male puberty from their women’s events ahead of the Paris Olympics.

In Paris 16 months ago, a furor was created around women’s boxing and the eligibility of two gold medalists, Imane Khelif from Algeria and Lin Yu-ting of Taiwan.

World Boxing, the new body overseeing Olympic tournaments, has introduced the SRY gene test, which identifies the Y chromosome found in males. World Athletics and the International Ski and Snowboard Federation also have introduced the tests.

Coventry said Wednesday trying to find a consensus is “maybe not going to be the easiest thing to do.”

“But we are going to try our best to ensure that when we are talking about the female category, we are protecting the female category and we are doing that in the most fair way,” she said.

It is unclear how many, if any, transgender athletes are competing at an Olympic level of competition.

However, the Olympic Charter which codifies rules for the IOC and Olympic Games states: “The practice of sport is a human right … without discrimination of any kind in respect of internationally recognized human rights.”

“That stance is never going to change,” Coventry said Wednesday. “Sport is, at grassroot levels and in any form of recreation, for everybody and you should have access for everybody to partake.”

AP National Writer Eddie Pells in Denver contributed to this report

Renovations at MSP’s Terminal 1 bring modern, brighter look to airport

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Holiday travelers will see a more modern look with brighter lighting at Terminal 1 at Minneapolis-St. Paul International Airport.

The largest interior renovation of the terminal has been completed, according to the Metropolitan Airports Commission and Delta Air Lines. The two worked together on a $242 million project managed by Delta to create a “unified and modern design” for six of the airport’s seven concourses and 75 Delta gate hold rooms. Renovations began in the fall of 2023.

The airline has its second largest hub at MSP with a 70% passenger market share at the airport.

“In a matter of two years, we have witnessed a major transformation of the post-security areas of Terminal 1 that elevates the passenger experience — from the checkpoints to the gate areas,” said Brian Ryks, CEO of the MAC, which owns and operates MSP Airport, in a statement. “Delta has been a tremendous partner helping to deliver more modern spaces that enhance MSP’s award-winning customer service.”

Among the improvements — a new terrazzo or carpet flooring, wall finishes, LED lighting fixtures and other changes.

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Delta’s gate areas underwent “a full refresh, including new seating, carpeting, counters and signage,” according to MAC officials. The addition of “dynamic gate signs” will allow travelers to see flight and destination information quickly and from farther down the concourse.

The renovations began while the final phases of another, 10-year effort were underway to expand and modernize all the pre-security areas, according to MAC officials, including the makeover of checkpoints, ticketing and baggage claim. These improvements — known as the Airport Modernization Program — were finished this fall. The MAC invested $182.5 million in the Airport Modernization Program, and Delta contributed $60 million.