ByHeart, the company whose powdered infant formula has been linked to an outbreak of infant botulism, says all of its products may be contaminated with Clostridium botulinum type A.
In a Nov. 25 statement, the company reported that tests of 36 unopened cans of its formula yielded five positive results for botulism that sickens babies.
Since August, 31 confirmed cases of infant botulism have been recorded. 1. All babies were fed ByHeart powdered formula. Sick infants are spread across 15 states, according to the latest update from the Food and Drug Administration.
The California Department of Public Health reports that more than 100 babies across the country have received treatment for botulism poisoning. The only treatment for the disease, BabyBig, is produced in California.
ByHeart released the following statement:
“As soon as we learned of the infant botulism outbreak from the FDA, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in food safety testing, to test unopened boxes of the ByHeart product and initiated a nationwide recall. We tested 36 samples from three lots and, as reported on November 19, we received positive results for Clostridium botulinum type A in five of 36 samples out of three Based on these results, we cannot make a determination that all ByHeart formulas in all product lots may have been contaminated.
“We continue to focus on finding the root cause, through rigorous auditing of every step of our product development chain, from suppliers and raw materials to packaging and transportation. This includes testing more product samples.
“We would like to reiterate the critical guidance for parents and caregivers to immediately stop using ByHeart formula. We continue to strongly recommend monitoring for symptoms of infant botulism and contacting a healthcare professional immediately if your child develops symptoms.”
The company recalled all of its baby formula products — cans and take-home pouches — but the Food and Drug Administration reported that the products are still for sale in some stores, including Walmart stores. ByHeart’s statement said measures are in place in store records to stop the sale of its products.
According to the American Academy of Pediatrics, signs of infant botulism appear approximately 3 to 30 days after consuming the bacteria Clostridium botulinum. Symptoms often begin with constipation followed by difficulty feeding (sucking and swallowing), a weak, altered cry, diminished facial expression, drooping eyelids, loss of head control, and lethargy. The infection often leads to paralysis of the muscles used for breathing, requiring machine-assisted breathing.
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