An outbreak of infant botulism, a type of severe illness caused by the botulism toxin and linked to a recalled brand of baby formula, has increased by eight cases to a total of 23 across several states, federal officials have confirmed.
Suspected or confirmed cases of infant botulism have spanned 13 states so far, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) stated in advisories updated on Nov. 14.
Cases have been reported in Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, according to the agencies.
The botulism cases are linked to all ByHeart Whole Nutrition Infant Formula products, including unexpired lots of formula cans, according to the FDA. The products were available for sale online and in major retail stores across the United States.
For 22 of the 23 cases, the illnesses began on dates ranging between Aug. 9 and Nov. 11, the FDA stated. All 23 infants were hospitalized, but no deaths have been reported.
“As part of this investigation, officials in several states have collected leftover infant formula for testing,” the agency stated.
The FDA also noted that the “presence of the bacteria that produce botulinum toxin” was discovered in an opened can of ByHeart formula that was given to a child.
The company on Nov. 11 recalled all of its ByHeart Whole Nutrition infant formula products on Nov. 11, including all lot numbers and all sizes of cans and single-serving packets, according to the CDC.
The agency warned parents not to serve any of the ByHeart products and said that if parents have a leftover ByHeart product, they should label it, “DO NOT USE.” They should store it in a safe area for a month or more. If their infant develops signs of botulism, the product can be submitted to state officials for testing.
Parents and caregivers are advised to wash items and surfaces that may have touched the formula with hot and soapy water or in a dishwasher if possible, according to the CDC.
This past week, the company said in a statement: “We started this company to give parents confidence in what they feed their babies. So knowing that the past few days have caused confusion and fear for many of you has been heartbreaking, and we are so sorry.”
ByHeart stated that the recall was voluntarily initiated and that “no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.” The FDA stated in its alert that detecting the bacteria is difficult and stressed that a negative result doesn’t rule out the presence of the microbe.
The parents of two infants who were hospitalized with infant botulism have sued ByHeart, alleging negligence in manufacturing, storing, and distributing the products.
“Plaintiffs do not yet know whether there will be long-term effects, and that uncertainty remains with Plaintiffs every day,” lawyers for one of the families said in their complaint.
Symptoms of infant botulism include constipation, poor feeding, weak suckling, a loss of head and muscle control, drooping eyelids, lethargy, a lack of facial expression, and a weak cry, the Cleveland Clinic stated. Symptoms can progress to breathing difficulty, a stop in breathing, or paralysis.
A previous Epoch Times request for comment to ByHeart regarding the lawsuits was not returned.