ByHeart is expanding its infant formula recall to include all lots of cans of ByHeart Whole Nutrition and Anywhere Pack infant formula nationwide. The formula has been linked to an outbreak of infant botulism.
The California Department of Public Health tested the ByHeart formula in patients’ homes and found botulism contamination that matched a patient’s bacteria.
There are 15 patients in the outbreak so far. Patients are spread across 12 states.
The FDA and CDC conducted a broader investigation into a spike of 84 cases of infant botulism that began in August.
As the FDA awaits confirmed test results, ByHeart:
- Recalling all products from the market as the FDA’s in-depth investigation seeks to identify the root cause of the broader outbreak.
- Test each batch of formula with an independent third-party laboratory
- Providing the FDA and the California Department of Public Health with full access to its facilities and unopened boxes of preparation to conduct testing without restriction
- Publicly share regulatory and independent test results as they become available
Infant botulism is a rare but serious disease that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature intestine of infants. Affected infants may have some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cries, generalized weakness, difficulty breathing, and possible respiratory arrest. If your child has any of these symptoms, please seek medical attention immediately.
Consumers who purchased ByHeart Whole Nutrition infant formula cans and Anywhere Pack pouches should immediately stop using and throw away the product.
If your infant has symptoms related to infant botulism, contact your healthcare provider immediately.
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