ByHeart Recalls All Baby Formula After Botulism Outbreak: A Look At The Overall US Formula Market
Organic baby formula maker, ByHeart, is voluntarily recalling all of its product, after the U.S. Food and Drug Administration (FDA) linked it to more than a dozen cases of infant food poisoning across the country.
Federal officials said 15 children, ages 2 weeks to five months, were hospitalized after consuming ByHeart Whole Nutrition Infant Formula – part of a botulism outbreak across 12 states since August, according to the CDC. No deaths have been reported so far.
While the recall is not expected to spark a nationwide shortage like was seen in 2022, it is a blow to efforts made in recent years to diversify and modernize the U.S. baby formula market.
MORE INTO THE INVESTIGATION
ByHeart officials expanded the voluntary recall from two lots announced Saturday to all products in consumers’ homes and in stores as of Tuesday. That includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company notes that infant botulism has never before been tied to infant formula.
Preliminary testing by California health officials “suggest the presence” of the type of bacteria that could produce botulism in a can of the company’s powdered formula. More testing is ongoing, both by the company and U.S. health officials.
What it is: Infant botulism occurs when babies consume a type of bacteria that produces a toxin in their large intestine. Symptoms include constipation, poor feeding, and drooping eyelids.
Though it can lead to paralysis or death in rare cases, infant botulism is very treatable and has a survival rate of between 98-100%, according to the Cleveland Clinic.
Timing: Botulism can take weeks to develop, so the FDA is advising parents who have fed their children ByHeart to keep a close eye on them. Here are some alternative formula options.
BIGGER PICTURE
ByHeart products make up less than 1% of infant formula sold in the U.S., according to the FDA. So a nationwide formula shortage is unlikely. The company is one of the few new U.S. brands in a formula market long-dominated by just a handful of companies using decades-old recipes.
It became clear how fragile the baby formula supply chain in the U.S. is after the 2022 Abbott Nutrition plant shutdown, which triggered nationwide shortages.
While infections involving Cronobacter sakazakii and Salmonella Newport were reported in five infants — two of whom died — federal officials never found a direct link to the plant.
Since then, the FDA has stepped up oversight and developed new strategies to prevent bacterial contamination, according to their Jan. 2025 report. The agency says it’s also working to diversify and stabilize the formula market by supporting new manufacturers and aligning U.S. standards more closely with international ones.
Still, the industry remains highly reliant on three major producers. In March, Health Secretary Robert F. Kennedy Jr. launched Operation Stork Speed — the first comprehensive review of infant formula nutrition standards since 1998 — to modernize the system and strengthen supply security.