The U.S. Food and Drug Administration (FDA) has sent warning letters to major retailers including Albertsons, Kroger, Target and Walmart for failing to remove recalled ByHeart infant formula products — which has been linked to at least 51 infant botulism cases — from store shelves.
All of ByHeart’s Whole Nutrition Infant Formula products, including all cans and Anywhere Pack single-serve sticks, were voluntarily recalled online and in stores on Nov. 11. ByHeart’s infant formula products have been linked to an outbreak of infant botulism, a type of severe illness caused by botulinum toxin, according to the Centers for Disease Control and Prevention (CDC) and the FDA.
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According to a press release, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not available to consumers. They discovered that the recalled infant formula continued to be found on store shelves. The warning letters highlight the responsibility retailers have in implementing a recall, particularly while dealing with products that affect the health of vulnerable populations, such as infants.
“Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food,” said FDA Commissioner Marty Makary.
Walmart said in a statement to ABC news, “The health and safety of our customers and members is always a top priority. When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online. We take all reports of inaction seriously and will respond to the letter.”
Meanwhile Albertsons Companies said “At Albertsons Companies, we are committed to the health and safety of our customers. We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items and communicate guidance to customers. ByHeart infant formula products have been removed from our store shelves.”
ByHeart president and co-founder Mia Funt previously said that “the safety and well‑being of every infant who uses our formula is, and always will be, our highest priority.”
ByHeart had said that as soon as it learned about the outbreak, the company partnered with IEH Laboratories & Consulting Group to “test un-opened cans of ByHeart product, and conducted a nationwide recall.”
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“We tested 36 samples from three lots and … received positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company said at the time, adding that the company would continue to focus on finding the root cause.
Botulism is a rare but serious illness. According to the CDC, botulinum toxin can attack the nerves, leading to difficulty breathing, muscle weakness and paralysis, visual disturbances, trouble swallowing, speech issues and, in some instances, death. Symptoms of infant botulism can include poor feeding, constipation, pupils that are slow to react to light, drooping eyelids, fewer facial expressions than usual, low muscle tone or a weaker-than-normal cry.