Home Care In Allerton, IA

ByHeart, a baby formula manufacturer with a plant in the southern Iowa city of Allerton, has issued a nationwide voluntary recall of its products over concerns about cases of botulism in infants that have consumed it.

In a statement issued Tuesday, Nov. 11, on its website, the New York-based company said the move was being made to “ensure your baby’s safety.”

The company did not immediately respond to emails from the Des Moines Register.

The announcement extending the recall to all ByHeart products ? both canned formula powder and the company's single-serve Anywhere Pack sticks ? follows an announcement Monday that it as recalling two specific lots of baby formula.

The U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention, along with state health departments, are investigating an outbreak of infant botulism in 10 states. There have been 13 cases documented in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, according to a Nov. 8 FDA statement.

The federal health agencies noted that all 13 cases in the outbreak, which began in August, were reported to have involved consumption of ByHeart powdered infant formula.

In its statement, ByHeart said, “Neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula.”

But ByHeart’s statement said the company decided to broaden the recall to all of its products after a call late Monday from the FDA notifying it that two more cases of botulism had been detected in babies that had consumed its formula, bringing the total to 15.

"The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions," the company said.

In addition to conducting is own testing, ByHeart said it is providing health agencies with “complete and unrestricted access to all of our facilities and products for their investigation.”

The FDA said officials in several states have collected leftover infant formula for testing. Results are expected in coming weeks.

“At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision,” ByHeart said in its statement, adding that it is providing information on how to switch formula on its website, byheart.com.

Most infants with botulism initially will develop constipation, poor appetite, loss of head control and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest, according to the FDA. It said symptoms can take as long as several weeks to develop following formula ingestion.

ByHeart products represent less than 1% of all infant formula sold in the United States and the recall will not impact the national supply of baby formula, according to the FDA.

Founded in 2016, ByHeart has manufacturing facilities in Reading, Pennsylvania and Portland, Oregon, as well as Allerton. It purchased the Allerton facility from DairiConcepts, a subsidiary of Dairy Farmers of America, in January of 2023.

(This story was edited to add a photo.)

Kevin Baskins covers jobs and the economy for the Des Moines Register. Reach him at [email protected].

The California Department of Public Health (CDPH) has tested a can of ByHeart powdered infant formula that was fed to an infant who later developed infant botulism. Preliminary results indicate the presence of botulinum toxin-producing bacteria in the sample consisten with the type of toxin reported from confirmed outbreak cases.

As of November 8, 2025, 13 infants with suspected or confirmed infant botulism have been reported from 10 states, according to the CDC: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.

Eight of the 13 cases have been confirmed as Type A botulism; the remaining five cases are still under investigation. Illnesses started on dates ranging from mid-August to November 2025. All 13 infants were hospitalized and treated with BabyBIG® (an antitoxin for infant botulism developed and supplied by the CDPH). No deaths have been reported. Infants ranged in age from 16 to 157 days.

Interviews conducted with caregivers for the 13 outbreak victims revealed that all 13 (100%) infants were fed ByHeart Whole Nutrition infant formula.

In response to the findings, ByHeart Inc. has recalled the following two batches of ByHeart Whole Nutrition Infant Formula (UPC: 5004496800):

ByHeart’s inspection history

ByHeart Inc. is the parent company for three manufacturing / packaging facilities:

Of these, the Reading facility manufactures the infant formula base product, which is then blended and packaged at a different facility.

The Reading location achieved its FDA registration on April 28, 2022 and was subjected to an initial, and successful, FDA inspection in June of 2022.

Then, the Cronobacter sakazakii tsunami hit, and the FDA chose to take an in-depth look at all of the powdered infant formula manufacturing sites, including ByHeart’s Reading facility. What they found was disturbing, resulting in both inspections being classified as “Official Action Indicated.”

The FDA investigation team uncovered numerous problems, which were summarized in a Warning Letter, dated August 30, 2023. These included

The FDA conducted its next inspection eleven months later. According to information posted on the FDA’s inspection data dashboard, investigators uncovered several serious problems.

Tempest in a teapot?

The ByHeart recall notice appears to make light of the probability that the company’s products are the source of the 13 cases of infant botulism, stating, “The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”

However, Clostridium botulinum is a common inhabitant of soil. This spore-forming bacterium also is relatively resistant to heat, and has the ability to endure long exposure to dry conditions. Poor sanitation, inadequate temperature control, and inadequate pest control are all routes by which this microbe can find its way into a powdered product.

Infant botulism, unlike the form of the ailment that attacks the general population, does not require pre-formed toxin to be present in the product. An infant’s digestive system can become infected by spores that are ingested or inhaled and set up an infection in the intestine.

In 2005, researchers in the United Kingdom described a case of infant botulism that appeared to be linked to consumption of contaminated powdered infant formula, even recovering a strain of Clostridium botulinum from a sample of the formula. However, in that case, genetic profiling suggested that the strain recovered from the formula was not the same as the one responsible for the illness.

Most prior cases of infant botulism have been traced to ingestion of soil or honey products. Nevertheless, caregivers and medical professionals must be on the alert. Untreated, infant botulism can be deadly. It should never be taken lightly.

What caregivers should do

Symptoms of infant botulism

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