Nationwide Health Alert Issued for ByHeart Infant Formula
Parents across the United Kingdom are being urged to immediately stop using ByHeart infant formula after the manufacturer confirmed that all of its product lots may be contaminated with bacteria that can cause botulism. This alarming development follows laboratory tests connected to an ongoing outbreak that has already sickened dozens of infants.
Laboratory Tests Confirm Widespread Contamination Risk
The company announced on Monday that tests on 36 samples from three different lots revealed a disturbing finding: five samples contained Clostridium botulinum type A. This is the specific bacteria that can lead to infant botulism, a rare but potentially fatal illness. "Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," the company stated in a formal update on its website.
The initial recall was issued on November 11, 2025. However, a significant concern remains as both state officials and the U.S. Food and Drug Administration (FDA) have reported that some of the recalled product is still present on store shelves.
Dozens of Infants Sickened in Multi-State Outbreak
The human cost of this contamination is already severe. According to federal and state health authorities, at least 31 babies across 15 states have fallen ill after consuming the formula in an outbreak that began in August. Disturbingly, officials have also indicated that other infants were treated for botulism in earlier months, with cases traced back as far as November 2024, though these are not formally counted in the current outbreak tally.
Medical experts have clarified that the bacteria can be unevenly distributed in powdered formula, meaning not every baby who ingests it will become sick. Nevertheless, all infants under the age of one are considered to be at risk.
Critical Information for Parents and Caregivers
Health officials are issuing urgent guidance to parents and caregivers. They must:
- Stop feeding ByHeart formula to babies immediately.
- Monitor children closely for symptoms, which can take up to 30 days to appear.
Symptoms of infant botulism require immediate medical attention and include:
- Constipation
- Difficulty sucking or feeding
- Drooping eyelids
- A flat facial expression
- Weakness in the arms, legs, and head
The illness is a medical emergency that occurs when spores germinate in a baby's intestine and produce a toxin. Treatment often involves an IV medication known as BabyBIG. Since August 1, at least 107 babies nationwide have received this treatment—a significant number given that typically, fewer than 200 infant botulism cases are treated in an entire year.
Consumers who purchased formula directly from the ByHeart website on or after August 1 are now eligible for a full refund, an expansion of the company's previous policy. To report an illness, individuals should contact an FDA consumer complaint coordinator or use the online MedWatch form.
