A company at the center of a multi-state baby formula recall due to a botulism bacterial contamination said Monday that all lots of its formula may be contaminated.
ByHeart said in an update on its website that it conducted testing on 36 samples from three different lots of its baby formula, showing that five samples contained the type of bacteria that can lead to the potentially deadly infection in infants.
“Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote in the update.
At least 31 babies in 15 states who consumed ByHeart formula have been sickened in the outbreak that began in August, according to federal and state health officials. In addition, other infants who drank ByHeart formula were treated for botulism in earlier months, as far back as November 2024, although they are not counted in the outbreak, officials have said.
ByHeart said earlier this month that all of its formula was recalled nationwide. However, some of its products have remained on store shelves during the recall, said state officials and the federal Food and Drug Administration (FDA).
In a recent update, the FDA said it has obtained reports that some of the recalled ByHeart products can still be found in several states, including at Walmart, Kroger, and Target retail locations. Other retailers that were flagged by the FDA include Safeway, Shaw’s, Star Market, Sprouts Organic Market, and Jewel-Osco.
The FDA said it is “working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country,” noting that the products “should not be available for sale in stores or online.” That includes ByHeart single-serve Anywhere Pack sticks and its formula cans, the agency said.
Last week, the Centers for Disease Control and Prevention (CDC) said all of the 31 infants who were sickened with botulism were hospitalized. According to a map posted by the FDA, states reporting cases include Washington, Oregon, California, Arizona, Idaho, Texas, Minnesota, Illinois, Michigan, Kentucky, North Carolina, Pennsylvania, New Jersey, Rhode Island, and Maine.
Consumers who bought ByHeart on the company’s website on or after Aug. 1 can receive a full refund, an expansion of its previous policy, the company said.
Clostridium botulinum type A, the type of bacteria detected in the lots, can be unevenly distributed in powdered formula, officials said. Federal officials have said that parents and caregivers should be aware of botulism symptoms in infants if they consumed the products in recent days.
Most infants who are suffering from infant botulism will first develop constipation, poor feeding, loss of head control, and difficulty swallowing, the CDC said. Untreated cases may lead to the child experiencing a progressive type of paralysis that can lead to breathing problems and hospitalization.
Caregivers and parents are advised to seek immediate medical attention if an infant consumed ByHeart Whole Nutrition Infant Formula and has symptoms including loss of head control, difficulty swallowing, decreased facial expression, and poor feeding, the agency said. It noted that symptoms can take weeks to appear.
The Associated Press contributed to this report.