ByHeart has expanded its voluntary recall to include all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack, as confirmed by the U.S. Food and Drug Administration (FDA). This decision follows a broader investigation into a concerning spike in infant botulism cases, with a total of **84 cases** reported since **August 2023**.
No unopened ByHeart products have tested positive for *Clostridium botulinum* spores or toxins to date. Nevertheless, the FDA is actively awaiting confirmed results from its ongoing testing efforts. As part of its proactive measures, ByHeart is collaborating with an independent third-party laboratory to conduct further testing of its formula.
Details of the Recall
The voluntary recall specifically applies to ByHeart can UPC **85004496800** and Anywhere Pack UPC **85004496802**. The recall is a precautionary step aimed at ensuring consumer safety, particularly given the serious nature of infant botulism. This rare but dangerous condition arises when *Clostridium botulinum* spores are ingested and proceed to colonize in the intestinal tract, leading to the production of neurotoxins.
Symptoms of infant botulism can be severe and include constipation, poor feeding, drooping eyelids (ptosis), sluggish pupils, low muscle tone, and difficulty with sucking and swallowing. Parents should be vigilant for signs such as a weak or altered cry, generalized weakness, respiratory difficulties, and in extreme cases, respiratory arrest. If any of these symptoms appear, consulting a healthcare provider immediately is crucial.
Consumer Guidance and Reporting
Consumers who have purchased the affected products are advised to dispose of them promptly. For those seeking additional information or wishing to report any illnesses or adverse events, several resources are available. They can call an FDA Consumer Complaint Coordinator or complete an electronic Voluntary MedWatch form online. Additionally, ByHeart can be contacted directly at **[email protected]** or via their customer service line at **833-429-4327**, which is operational 24 hours a day, seven days a week.
For food safety inquiries, the USDA meat and poultry hotline is available at **888-674-6854**, or consumers can reach out to them via the Ask USDA chat service from **10 a.m. to 6 p.m.** on weekdays.
As the investigation continues, authorities stress the importance of consumer vigilance and prompt reporting of any health concerns related to the affected products. The safety of infants remains a top priority as both the FDA and CDC work to address this situation comprehensively.
