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ByHeart Recalls All Infant Formula Nationwide Amid Botulism Outbreak
ByHeart, a manufacturer of organic baby formula, has issued a nationwide recall for all of its products. This expanded recall comes days after initial batches were pulled from shelves due to an ongoing outbreak of infant botulism.
State and federal health officials report that at least 15 infants across 12 states have been hospitalized since August after consuming ByHeart formula, with more cases currently under investigation. Fortunately, no deaths have been reported.
The voluntary recall, initially announced on Saturday for two specific lots, has now been broadened to include all ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula in consumers’ homes and in stores.
Mia Funt and Ron Belldegrun, co-founders of ByHeart, stated in an open letter that the decision to expand the recall was made after the FDA informed them of two additional infant botulism cases linked to ByHeart formula. They emphasized that while the FDA’s investigation is ongoing and questions remain, the safety of babies is their top priority.
ByHeart typically sells approximately 200,000 cans of infant formula monthly through online channels and major retailers such as Target, Walmart, Albertsons, and Whole Foods. Dr. Devon Kuehn, chief medical officer, advises parents and caregivers to immediately discontinue use and dispose of any ByHeart formula they may have.
The company stated in a news release that the unusual recall was enacted “in close collaboration” with the U.S. Food and Drug Administration, despite the fact that no unopened ByHeart product has tested positive for contamination. Funt and Belldegrun reiterated that neither ByHeart, the FDA, nor the CDC have found Clostridium botulinum spores or toxins in any unopened can of their formula.
ByHeart will maintain the recall while the FDA investigates the outbreak’s cause. Concurrently, the company will implement independent third-party laboratory testing for every batch of formula and grant unrestricted access to its facilities and unopened products for testing by the FDA and California health officials.
California health officials previously confirmed the presence of the bacteria causing the botulism toxin in a sample from an open can of ByHeart formula fed to a sick infant.
The FDA is investigating 84 cases of infant botulism detected since August. Of these, 36 involved infant formula consumption, with over a third linked to ByHeart formula. The FDA highlighted that ByHeart brand formula is disproportionately represented among the sick infants in this outbreak, considering it accounts for an estimated 1% of all infant formula sales in the United States.
ByHeart manufactures formula powder at a plant in Allerton, Iowa, and then ships it to a site in Portland, Oregon, for canning and distribution. FDA inspectors were present at the Portland plant on Monday.
Infant botulism is a rare but serious illness affecting babies under one year old with immature gut microbiomes. It occurs when infants ingest bacteria containing spores that produce a toxin in the gut.
Symptoms include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, and breathing problems. Immediate medical attention is crucial for babies exhibiting these symptoms.
The sole treatment is BabyBIG, an IV medication derived from blood plasma.