ByHeart Inc., a next-generation baby nutrition company based in New York, has announced a nationwide expansion of its voluntary recall of its Whole Nutrition Infant Formula. This recall affects all batches of their 24 oz cans and Anywhere Pack™ products. The decision comes as a precautionary measure in collaboration with the U.S. Food and Drug Administration (FDA) amid concerns of potential contamination with Clostridium botulinum, a bacteria that can cause severe illness in infants.
Despite no confirmed cases of contamination in unopened products, ByHeart co-founder and president Mia Funt emphasized the company’s commitment to prioritizing infant safety. “The safety and well-being of every infant who uses our formula is our highest priority,” said Funt. The company has launched a comprehensive investigation to determine the possible cause of the broader outbreak of infant botulism cases that has been under scrutiny.
The recall announcement follows a spike in 84 infant botulism cases reported since August, prompting investigations by the FDA and the Centers for Disease Control and Prevention (CDC). ByHeart was alerted to the potential issue on November 7 and moved swiftly to implement a recall strategy.
As part of its proactive measures, ByHeart is:
– Recalling all products from the market while investigations continue
– Testing every batch of formula through an independent third-party laboratory
– Collaborating with the FDA and the California Department of Public Health (CDPH) by granting unrestricted access to its facilities and unopened cans for testing
– Committing to transparency by publicly sharing results from both regulatory and independent testing as they become available
Infant botulism is a serious illness that can manifest through various symptoms, including constipation, poor feeding, drooping eyelids, low muscle tone, and difficulty with sucking or swallowing. The company advises parents to seek immediate medical attention if their child exhibits any concerning symptoms.
Consumers who have purchased the affected products are encouraged to stop using them immediately and dispose of any remaining formula. For assistance, parents can reach ByHeart at hello@byheart.com or by calling 1 (833) 429-4327. Additional information is also available on their website.
This voluntary recall underscores ByHeart’s dedication to safety as the investigation into the incidents continues, with further steps to be determined based on the findings of the ongoing FDA inquiry.
