ByHeart says all of its products likely contaminated with Clostridium botulinum

ByHeart, the company whose powdered infant formula has been linked to an outbreak of infant botulism, is saying all of its products could be contaminated with Clostridium botulinum Type A.

In a statement on Nov. 25 the company reported that testing on 36 unopened cans of its formula resulted in five positives for the botulism that is causing babies to become sick. 

There are 31 confirmed cases of infant botulism since August. 1. All of the babies were fed ByHeart powdered infant formula. The sick infants are spread across 15 states, as of the latest update by the Food and Drug Administration. 

The California Department of Public Health is reporting 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 issued the following statement:

“As soon as we learned from FDA of the infant botulism outbreak, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in food safety testing, to test un-opened cans of ByHeart product, and conducted a nationwide recall. We tested 36 samples from three lots and, as shared on Nov. 19, we received positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.

“We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples.

“We want to reaffirm the critical direction for parents and caregivers to stop using ByHeart formula immediately. We continue to strongly recommend monitoring for symptoms of infant botulism and to contact a medical professional immediately if your child develops symptoms.”

The company has recalled all of its formula products — cans and to-go pouches — but the Food and Drug Administration has reported that the products are still on sale at some stores, including Walmart stores. ByHeart’s statement said there are measures in place at store registers to stop the sale of its products.

According to the American Academy of Pediatrics, the signs of infant botulism appear at an estimated 3 to 30 days from the time of consumption of the Clostridium botulinum bacteria. Symptoms often begin with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy. The infection often leads to paralysis of muscles used for breathing, resulting in the need for machine assisted breathing. 

(To sign up for a free subscription to Food Safety News, click here)