As infant botulism cases climb to 31, recalled ByHeart baby formula is still on some store shelves

As cases of fatal botulism in children drinking ByHeart infant formula continue to grow, state officials say they are still finding the recalled product on some store shelves.

Meanwhile, the company said late Wednesday that laboratory tests confirmed that some formula samples were contaminated with the type of bacteria that sickened more than 30 children in the outbreak.

The company said on its website that tests conducted by an independent food safety laboratory found Clostridium botulinum, a bacteria that produces toxins that can lead to diseases that may threaten the lives of children under one year old. ByHeart officials said they reported the results to the FDA but did not specify how many samples were tested or how many tested positive.

Steven Dexter holds a container of ByHeart infant formula, which was recently recalled by ByHeart Corporation, in Flagstaff, Arizona, on Wednesday, November 12, 2025.

AP Photo/Shayan Mumphrey

“We are working to investigate the facts, conduct ongoing testing to determine the source, and ensure this never happens to the families again,” ByHeart said on its website.

The US Food and Drug Administration did not immediately respond to questions about the results.

The lab findings come as investigators in at least three states found the ByHeart formula was still on sale even after the New York-based company recalled all products nationwide, officials told The Associated Press.

At least 31 children in 15 states who drank ByHeart formula have been hospitalized and treated for childhood botulism since August, federal health officials said Wednesday. They range in age from about 2 weeks to about 6 months, with the most recent case reported on November 13.

No deaths were reported.

In Oregon, a state agricultural official said nine of more than 150 stores checked still had the formula on shelves this week. In Minnesota, investigators conducted 119 inspections between Nov. 13 and 17, removing recalled products from sale at four locations, an Agriculture Department official said. An Arizona health official also said they found the product available.

Minnesota officials said in a statement that businesses and consumers should remain alert. “No affected product should be sold or consumed,” they wrote.

Investigators from the US Food and Drug Administration conducted inspections at ByHeart factories in Allerton, Iowa, and Portland, Oregon. No results from the inspections were reported.

Officials in California previously confirmed the presence of the germ that can lead to illness in an open container of ByHeart formula that was fed to a child who became ill.

Botulism in infants, which can cause paralysis and death, is caused by a type of bacteria that forms spores that germinate in the baby’s intestines and produce a toxin.

Symptoms can take up to 30 days to appear and include constipation, poor feeding, weak crying, drooping eyelids, or flat facial expressions. Children can develop weakness in their limbs and head and may feel “flabby.” They may have difficulty swallowing or breathing.

ByHeart was making about 200,000 cartons of formula a month. It is sold online or in retail stores such as Target and Walmart. A Walmart spokesperson said the company quickly issued a restriction preventing the sale of the formula, removed the product from stores and notified consumers who purchased it. Customers can visit any store to redeem the formula, which retails for about $42 per box.

Federal and state health officials are concerned that some parents and caregivers may still have ByHeart products in their homes. They advise consumers to stop using the product, including boxed formula and any single-serve sticks. They also suggest marking it as “Do Not Use” and keeping it for at least a month in case the child develops symptoms. In this case, the formula should be tested.

The California Department of Health runs the Infant Botulism Treatment and Prevention Program, which tracks cases and distributes treatment for the disease. Officials there have launched a public hotline at 833-398-2022, which is staffed by health officials from 7 a.m. to 11 p.m. PT.

The new hotline was created after calls from hundreds of parents and caregivers flooded a different, long-standing hotline for doctors to discuss suspected cases of food poisoning in children, officials said.

Copyright © 2025 The Associated Press. All rights reserved.

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