ByHeart Inc. has found Clostridium botulinum — which causes botulism poisoning — in unopened containers of its powdered infant formula. And, the FDA has found that several major retailers are continuing to sell the recalled formula while an outbreak is ongoing.
In an update today, the Food and Drug Administration reported officials are still finding the ByHeart formula products on store shelves, despite a recall of all of the company’s products. The infant formula is still being found in multiple states, including at multiple Walmart, Target and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s and Star Market locations.
As of Nov. 19, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula have been reported from 15 states. Laboratory confirmation for some cases is ongoing.
For 27 cases with illness onset information available, illnesses started on dates ranging from Aug. 9 to Nov. 13. All 31 infants were hospitalized. No deaths have been reported to date. The sick babies range in age from 17 to 200 days. Public health officials report that there has been a spike of infant botulism cases, with 84 having been reported since Aug. 1. Investigators are working to determine if all 84 of the sick babies were fed ByHeart formula.
As part of the outbreak investigation, ByHeart tested unopened infant formula products retained at its production facility. According to ByHeart, third party laboratory analysis of some of these samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak. ByHeart says it will continue to investigate these findings and perform ongoing testing to identify the source of contamination.
Earlier in the investigation, officials in several states began collecting leftover infant formula for testing. On Nov. 8, the California Department of Public Health (CDPH) preliminarily detected the presence of botulinum neurotoxin type A in a culture of ByHeart powdered infant formula from an opened can that was fed to a baby with laboratory confirmed infant botulism. Additional work by CDPH confirmed the identification of the bacterium, Clostridium botulinum type A from the culture.
Additional testing by FDA, CDC, and state partners is underway, and results are expected in the coming weeks. According to the FDA, detection of Clostridium botulinum in infant formula is complex, and a negative test result does not rule out the presence of the bacteria in the product.
The problems at one ByHeart production facility have been going on since at least 2022, according to an FDA warning letter sent to the company on Aug. 2, 2023.
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