ByHeart infant formula recalled over botulism outbreak : NPR

An infant formula linked to a botulism outbreak that has sickened dozens of children in 15 states may still be on store shelves even after it was recalled, federal health officials say.

As of Wednesday This was reported by the Food and Drug Administration (FDA).Thirty-one cases of suspected or confirmed infant botulism were reported in infants who consumed ByHeart Whole Nutrition formula and became ill between August and mid-November.

No deaths were reported. But all 31 children were hospitalized with a condition that could potentially cause a life-threatening form of gradual paralysis in children under one year of age.

“Epidemiological and laboratory data indicate that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum, which causes childhood illnesses in many areas of the country,” the FDA said.

Earlier this month, ByHeart Whole Nutrition recalled two lots of its infant formula. review extension on all of its products, including cans and single-serve pouches, last week. They are sold at major retailers, including Target, Publix, Walmart and Whole Foods, and online nationwide, with some products shipped to customers outside the United States.

ByHeart, which describes itself as a “next generation baby nutrition company,” first hit the market in 2022. The FDA says its products make up “approximately 1%” of all infant formula sold in the United States, so it has no concerns about potential shortage.

IN apology note In a message to parents, ByHeart says it is working with the FDA and “investigating every aspect of our process” to determine the cause of the outbreak.

In the meantime, the company, along with the FDA, is urging adults to stop using formula and monitor their children for symptoms of botulism. The FDA is also asking stores to stop selling the product.

But in a statement Wednesday, the agency said it had “received reports that the recalled formula is still on store shelves in many states.” NPR reached out to the FDA for more information but had not heard back by press time.

The FDA says it is working with government partners and retailers “to ensure an effective recall” as the investigation into the outbreak continues.

What do we know about the outbreak

As of Wednesday FDA said 31 cases were reported in 15 states: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

The outbreak has intensified since the FDA first announced its investigation on November 8. At the time, it said that of the approximately 83 cases of infant botulism reported nationwide since August, 13 infants had been exposed to ByHeart formula at some point.

This raised alarm bells because botulism in dairy products is rare and “there is no historical precedent for infant formula causing infant botulism,” the FDA said.

In response, ByHeart promptly recalled two lots of its products. The next day, he announced that the California Department of Public Health tested a sample from one of these shipments and it came back positive for Clostridium botulinum, the bacterium that causes infant botulism.

This sample was taken from an open can, which ByHeart initially said does not prove its product is to blame (since bacteria can naturally occur in places like soil and dust). But in Frequently asked questions on his websiteit now says that further testing by an outside group also found bacteria in some samples of the unopened formula.

ByHeart says The FDA told him during a late-night call on November 10 that it had found two more cases of infant botulism in infants who consumed his formula. The next day, ByHeart, citing “too many unanswered questions,” recalled all of its products and issued information to parents about how to switch to another brand of formula.

What you need to know about infant botulism

Botulism is a rare but serious disease caused by Clostridium botulinum. When a child ingests the spores, “they grow in the intestines and produce a toxin,” according to Centers for Disease Control and Prevention (CDC).

Symptoms can appear 3 to 30 days after consuming the bacteria and usually begin with constipation, poor diet, difficulty swallowing, and loss of head control.

“If left untreated, infants with infant botulism develop progressive flaccid paralysis, which can lead to difficulty breathing and require several weeks of hospitalization,” says the Centers for Disease Control and Prevention (CDC).

Treatment for infant botulism involves an antitoxin known as BabyBIG, which is given intravenously.

The CDC says parents should remain vigilant for several weeks after their baby last consumed ByHeart formula. They are advised to wash contaminated surfaces, label any remaining powder with “DO NOT USE” and store it in a safe place for a month in case the child develops symptoms and the state health department wants to test it.

The CDC says parents should seek immediate medical attention if they see any warning signs and also directs them to care for the infant. Botulism Outbreak Hotline from the California Department of Public Health, which was created specifically to respond to this outbreak.

What does the company do?

ByHeart says it conducts its own “extensive testing” and provides the FDA with “full and unrestricted access to all of our facilities and products for research.”

The company released more resources for customers in the days since the recall, such as a 24-hour support hotline and refunds on purchases since October.

He has also promised introduce more stringent safety measures and testing in the future, saying Clostridium botulinum “is not among the pathogens routinely tested in the industry” – until now.

Meanwhile, several affected family members filed a lawsuit.

The parents of two 4-month-old babies hospitalized with infant botulism in Arizona and Kentucky filed separate federal trials last week. They accused ByHeart of negligence and are seeking compensation for medical bills and emotional suffering after both of their daughters required hospitalization. Separate class action filed in New York, accused of deceptive marketing.

ByHeart told NPR via email that it could not comment on the lawsuit, but reiterated its commitment to supporting the families and the FDA investigation.