ByHeart Recalls Infant Formula Due to Botulism Outbreak: NPR
ByHeart is initiating a comprehensive recall of its infant formula products due to links with a serious botulism outbreak affecting numerous infants in multiple states. This recall encompasses all variants of ByHeart Whole Nutrition formula, which have been available in cans and single-serve packets in stores and online.
Botulism Outbreak Linked to ByHeart Products
As of mid-November, the Food and Drug Administration (FDA) has identified 31 cases of suspected or confirmed infant botulism related to ByHeart formula. The infants affected fall within a troubling age bracket of under one year old. Fortunately, no fatalities have been reported, but all hospitalized infants face potentially life-threatening health risks.
Details of the Recall
The FDA’s findings point to contamination by Clostridium botulinum in ByHeart’s products. In response, the company initially recalled two batches but later extended the recall to encompass all products. They have been widely distributed across major retailers, including Target, Walmart, and Whole Foods, as well as sold online, with some shipments sent outside the United States.
- States Affected: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
- Hospitalization: All 31 reported cases required hospitalization.
Health Advisory for Parents
The FDA and ByHeart are advising parents to discontinue use of the formula and closely monitor their infants for any signs of botulism. Additionally, all retailers are urged to remove the products from their shelves. Despite the recall, some reports indicate that the tainted formula remains on store shelves.
Understanding Infant Botulism
Infant botulism is a rare but serious condition caused by ingesting spores of Clostridium botulinum. Symptoms may develop between three and 30 days after exposure and often begin with:
- Constipation
- Poor feeding
- Difficulty swallowing
- Loss of head control
If not treated, the condition can lead to progressive paralysis and breathing difficulties, necessitating prolonged hospitalization. The primary treatment involves an antitoxin administered through IV.
Next Steps for Affected Families
Parents are encouraged to wash contaminated surfaces and safely store any remaining formula marked as “DO NOT USE” for a month. This precaution allows health officials to conduct necessary testing if symptoms manifest.
Response from ByHeart
ByHeart is currently collaborating with the FDA for a thorough investigation and has pledged to improve testing and safety protocols. The company has established a support hotline for concerned customers and is offering refunds for recent purchases. Meanwhile, some affected families are pursuing legal action, citing negligence and seeking compensation for medical expenses and emotional distress.
ByHeart has reiterated its commitment to supporting affected families and maintaining transparency with the ongoing FDA investigation. Further updates regarding this incident will be communicated as more information becomes available.
