ByHeart is expanding its infant formula recall to include all shipments of ByHeart Whole Nutrition and Anywhere Pack infant formula cans nationwide. This mixture has been linked to an outbreak of infant botulism.
The California Department of Public Health conducted the testing. ByHeart Formula from patients' homes and found botulism contamination that matched the patient's bacteria.
There are currently 15 patients in the outbreak. Patients are scattered across 12 states.
The FDA and CDC are conducting a broader investigation into a spike of 84 cases of infant botulism that began in August.
While the FDA awaits confirmed results from its trials, ByHeart:
- A recall of all products from the market while a comprehensive FDA investigation is aimed at identifying the root cause of the broader outbreak.
- Each batch of formula is tested by an independent third party laboratory.
- Allowing the FDA and the California Department of Public Health full access to their facilities and unopened cans of formula to conduct testing without restrictions.
- Public dissemination of both regulatory and independent test results as they become available.
Infant botulism is a rare but serious disease that occurs when Clostridium botulinum spores enter the body and then colonize the intestinal tract, producing botulinum neurotoxins in infants' immature intestines. Affected infants may have some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelids), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, general weakness, difficulty breathing, and possible respiratory arrest. If your child has any of these symptoms, get medical help right away.
Consumers who purchased ByHeart Whole Nutrition Baby Food Jars and Anywhere Packs should immediately stop using and discard the product.
If your child has symptoms of infant botulism, contact your doctor immediately.
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