The FDA, CDC, California Department of Public Health and state and local partners are investigating a ten-state outbreak of infant botulism that has sickened 13 infants so far.
Caregivers for all thirteen infants reported feeding ByHeart Whole Nutrition infant formula.
Illnesses have been reported in Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). These totals include both suspected and confirmed cases.
The thirteen victims range in age from 16 to 157 days. All thirteen have been hospitalized and treated with BabyBIG®, an antidote to infant botulism.
Several states have collected leftover samples of infant formula for testing; work is in progress, but the results are not yet available.
The FDA has recommended that the manufacturer, ByHeart Inc., initate a recall. The company has complied and is recalling the following two lots, which were reported to have been consumed by the infants:
- ByHeart Whole Nutrition Infant formula:- Lot no. 206VABP/251261P2 and Lot no. 206VABP/251131P2)
What consumers and caregivers need to know
How to identify infant botulism
Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make toxin in it.
Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. Symptoms can progress to difficulty breathing and respiratory arrest.
Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
What actions to take
- Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
- Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
- If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.
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