ByHeart, the company whose powdered infant formula has been linked to the infant botulism outbreak, says all of its products may be contaminated with Clostridium botulinum Type A.
In a Nov. 25 statement, the company said testing of 36 unopened cans of its formula yielded five positive results for botulism, which causes the disease in infants.
There have been 31 confirmed cases of infant botulism since August. 1. All children were fed ByHeart powdered infant formula. Sick babies are scattered across 15 states, according to the latest data from the Food and Drug Administration.
The California Department of Public Health reports that more than 100 infants across the country have been treated for botulism poisoning. The only remedy for this disease, BabyBig, is made in California.
ByHeart released the following statement:
“As soon as we learned from the FDA of the infant botulism outbreak, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in food safety testing, to test unopened cans of ByHeart and conducted a nationwide recall. We tested 36 samples from three lots and, as reported on November 19, we received positive test results for Clostridium botulinum type A in five of 36 samples in all three lots. Based on Based on these results, we cannot rule out the risk that all ByHeart mixtures in all product lots may be contaminated.
“We remain focused on finding the root cause through a thorough audit of every stage of our product development chain, from suppliers and raw materials to packaging and transportation. This includes testing more product samples.
“We want to reiterate the extremely important 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 products – cans and To-Go bags – but the Food and Drug Administration said the products are still sold in some stores, including Walmart stores. ByHeart said in a statement that measures have been taken at store checkouts to stop selling its products.
According to the American Academy of Pediatrics, signs of infant botulism appear approximately 3 to 30 days after ingestion of Clostridium botulinum bacteria. Symptoms often begin with constipation, followed by difficulty feeding (sucking and swallowing), weak and altered crying, worsened facial expression, drooping eyelids, loss of head control, and lethargy. The infection often leads to paralysis of the muscles used for breathing, resulting in the need for artificial respiration.
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