ByHeart Recalls Baby Formula After Infant Botulism Outbreak in 10 States
ByHeart, a producer of organic baby formula, is recalling certain lots of its Whole Nutrition Infant Formula. This recall comes after the U.S. Food and Drug Administration (FDA) linked the product to an infant botulism outbreak affecting ten states. Since August, 13 children have been hospitalized due to this condition, although no fatalities have been reported.
Details of the Recall
The FDA announced the recall of two specific lots of ByHeart’s powdered formula. These lots have use-by dates of December 1 and include the following lot numbers:
- 206VABP/251261P2
- 206VABP/251131P2
Parents and caregivers are advised to check the bottom of the packaging for these identifiers and dispose of the product immediately. The FDA is collaborating with retailers to remove all potentially affected products from sale.
Understanding Infant Botulism
Infant botulism is triggered by a toxin produced by bacteria and can lead to symptoms such as:
- Constipation
- Poor feeding
- Loss of head control
- Difficulty swallowing
In severe cases, this condition can result in paralysis or death. Due to the slow onset of botulism, the FDA recommends that guardians monitor infants who may have consumed the recalled formula.
Geographical Impact
Cases of infant botulism linked to ByHeart formula have been reported in the following states:
- Arizona
- California
- Illinois
- Minnesota
- New Jersey
- Oregon
- Pennsylvania
- Rhode Island
- Texas
- Washington
Company Statement
New York City-based ByHeart stated that they were notified by the FDA of 83 reports of infant botulism nationwide since August. They emphasized that their product had not shown traces of botulism through both government and internal testing. The company is committed to removing any potential risk from circulation to ensure infant safety.
Next Steps
The FDA is actively testing leftover ByHeart formula across several states. Results from these tests are anticipated in the coming weeks. The primary goal is to ascertain the contamination point and whether any additional products may be affected.
Composition and Market Presence
ByHeart’s infant formula consists of organic, grass-fed whole milk, which they claim is similar in composition to breast milk. Their products are available in nearly 12,000 retail locations. Notably, ByHeart’s share of the U.S. baby formula market is less than 1%.
Treatment for Infant Botulism
Infant botulism can be treated with BabyBIG, an FDA-approved medication that provides antibodies to combat botulinum neurotoxins. Parents and guardians should seek immediate medical attention if they suspect their child is exhibiting symptoms of this condition.
