Every affected baby was hospitalized after drinking ByHeart formula, officials confirmed. Luckily, no deaths have been reported so far. ByHeart first recalled two lots of formula on Saturday, but has now expanded the voluntary recall to all products in homes and stores, said company officials. The recall covers ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula.
ByHeart recall and FDA investigation
ByHeart sells about 200,000 cans of formula per month, both online and in stores such as Target, Walmart, Albertsons, and Whole Foods, said Dr. Devon Kuehn, chief medical officer, as per the report by ABC News. Parents and caregivers who have the formula at home “should immediately discontinue use and dispose of the product,” Kuehn warned.
The company said it launched the recall “in close collaboration” with the U.S. Food and Drug Administration (FDA), even though no unopened ByHeart product tested positive for contamination. California health officials found that a sample from an open can of ByHeart formula given to a sick baby contained the bacteria that causes the botulism toxin.
ByHeart said in a statement, “This action underscores ByHeart’s core mission: protecting babies above all else.” The FDA is investigating 84 cases of infant botulism detected since August. Out of these, 36 babies consumed infant formula, and more than one-third had ByHeart formula, the agency said.
What is infant botulism and its symptoms
The FDA stated, “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States”, as stated by ABC News. ByHeart makes its formula powder in Allerton, Iowa, and then ships it to Portland, Oregon, where it is canned and distributed, Kuehn said.FDA inspectors visited the Portland plant on Monday, according to Kuehn. The company is now checking every batch of baby formula in an independent lab. It is also sharing all test results with health officials and allowing them to visit its sites. Infant botulism is a very rare but serious sickness seen in babies under 1 year old. It happens because their stomachs are not fully developed.Babies can get this illness when they take in bacteria that make harmful toxins in their stomach. Symptoms include constipation, weak muscles, droopy eyelids, trouble feeding, swallowing, or breathing. Experts told ABC News that if a baby has these signs, parents should get medical help immediately.
FAQs
Q1. Why did ByHeart recall its baby formula?
ByHeart recalled all its baby formula products across the U.S. after several babies developed infant botulism linked to its formula, according to health officials.
Q2. What should parents do if they have ByHeart formula at home?
Parents should stop using the ByHeart formula immediately and safely dispose of it, as advised by the company and the FDA.