FDA Reports 31 Infant Botulism Cases Amid ByHeart Formula Recall
Concerns are growing as the U.S. Food and Drug Administration (FDA) reported a total of 31 cases of infant botulism linked to ByHeart infant formula. This update comes after the company expanded its recall earlier this month.
Details on the Infant Botulism Cases
Infants in 15 states have been hospitalized due to botulism symptoms related to ByHeart Whole Nutrition spray-dried infant formula. The cases have been reported since August 9, with the latest occurring on November 13. Thankfully, no fatalities have been recorded.
Symptoms of Infant Botulism
- Poor feeding
- Loss of head control
- Drooping eyelids
- Flat facial expression
- Floppy appearance
- Difficulty swallowing or breathing
The Centers for Disease Control and Prevention (CDC) notes that symptoms can take weeks to manifest. Parents should be vigilant if they notice these signs in their infants.
Recall and Ongoing Concerns
Despite the recall of all ByHeart infant formula products, reports indicate that the formula remains available on store shelves in various locations. The FDA’s warning extends to products that have been sold online and distributed outside the U.S.
ByHeart responded to the situation, stating, “We are doing everything we can to show up for parents.” The company assures consumers that it will provide updates as they become available.
Legal Actions Against ByHeart
Two families whose children were affected by botulism have initiated lawsuits against ByHeart. Filed in federal courts, these complaints claim that the formula was defective and that the company acted negligently. Plaintiffs are seeking compensation for medical expenses and emotional distress.
Understanding Infant Botulism
Infant botulism is caused by the bacterium Clostridium botulinum, which produces a harmful toxin in the intestines. The spores are commonly found in the environment and can lead to severe health issues, including paralysis.
The FDA is actively testing leftover infant formula for traces of the bacteria and is also examining unopened products. However, the agency warns that detecting Clostridium botulinum can be challenging. A negative test result does not necessarily confirm the absence of the bacterium in the product.
Results from ongoing tests are expected in the coming weeks, and health officials are urging consumers to stay informed about the ByHeart formula situation.
