Botulism Outbreak Forces Recall of All ByHeart Products: NPR
The recent outbreak of infant botulism has led to a widespread recall of ByHeart baby formula products. The U.S. Food and Drug Administration (FDA) included all ByHeart products due to potential contamination. This recall impacts all formulas made since the beginning of production in March 2022.
Scope of the Outbreak
The outbreak now includes at least 51 reported cases in 19 states. Health authorities have stated that any infant who has consumed ByHeart formula since its release could be affected. The Centers for Disease Control and Prevention (CDC) updated the case definition to include infants with botulism linked to the product.
Details and Impact
- The outbreak was initially reported on November 8, with 39 cases identified in 18 states.
- Contamination may have occurred across all production runs of ByHeart products.
- No fatalities have been reported due to the outbreak, but the most recent case occurred on December 1.
Company Response and Investigations
ByHeart, based in New York and founded in 2016, has recalled all of its U.S. products as of November 11. The company held a market share of approximately 1% in the infant formula sector, selling about 200,000 cans per month.
In a statement, ByHeart emphasized that it is cooperating with federal investigations and aims to determine the cause of the contamination. Recent testing revealed that 36 samples from different lots contained bacteria linked to infant botulism.
Previous Contamination Issues
- The company faced prior recalls in 2022 for five batches due to contamination with another germ.
- In 2023, an FDA warning letter highlighted unresolved corrective actions.
- A Reading, Pennsylvania, facility was shut down after inspections revealed serious hygiene issues.
Understanding Infant Botulism
Infant botulism is rare, affecting fewer than 200 infants in the U.S. annually. It occurs when spores of botulism bacteria germinate in the intestines, producing a toxin that disrupts the nervous system. Infants are particularly vulnerable due to their undeveloped gut microbiomes.
Symptoms vary and can take up to 30 days to manifest. They may include:
- Constipation
- Poor feeding
- Weak muscle control
- Drooping eyelids
- Flat facial expressions
The only treatment available is BabyBIG, an intravenous medication derived from the blood plasma of immunized adults.
Ongoing Legal Actions
Families of infants affected by botulism after consuming ByHeart formula have initiated lawsuits against the company. These legal actions claim negligence and seek compensation for medical expenses, emotional distress, and other damages.
As investigations continue, it remains critical for families to avoid the recalled ByHeart products to ensure the safety of their infants.
