Ongoing Concerns Over ByHeart Infant Formula Recall

On November 11, 2025, ByHeart Whole Nutrition powdered infant formula was recalled following an investigation by the California Department of Public Health, the U.S. Food and Drug Administration (FDA), and the U.S. Centers for Disease Control and Prevention (CDC). This action was prompted by an unusually high number of infant botulism cases linked to the formula, with 51 infants in 19 states reportedly affected. Symptoms of infant botulism can include constipation, fussiness, and muscle control loss, which may require hospitalization and extensive recovery efforts.

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Despite the recall, cans of ByHeart formula were still found on store shelves weeks later, raising concerns about compliance among retailers. Kroger, Target, Albertsons, and Walmart received warning letters from the FDA after inspectors discovered recalled products available for sale across 36 states. Bill Marler, a food safety attorney representing affected families, criticized the retailers for not acting swiftly enough to remove the product. Kroger stated that they had implemented measures to block sales of the recalled item, but did not clarify why it remained on shelves.

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The Consumer Product Safety Commission (CPSC) has noted that retailers often struggle to effectively communicate recalls to all employees, leading to lapses in compliance. Acting CPSC Chairman Peter Feldman highlighted that it is illegal to sell recalled products, yet instances of such sales persist. The CPSC has ramped up its efforts to monitor online sales of recalled goods, issuing 33,000 takedown orders in the past three months, a 150% increase from the previous year.

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Frank Yiannis, former FDA deputy commissioner, expressed disappointment over the slow response to the ByHeart recall, noting that the initial recall of only two lots created confusion. He emphasized the need for improved technology, such as RFID tags, to enhance product tracking and prevent similar issues in the future. Yiannis also pointed out that the FDA's new food traceability rule, intended to expedite the identification of contaminated products, has been delayed until 2028.

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ByHeart issued an apology for the distress caused by the recall, stating that independent testing found botulinum spores in 6 out of 36 samples. The company has paused production while auditing its supply chain for contamination sources. Sandra Eskin, CEO of Stop Foodborne Illness, criticized the failure of large companies to manage recalls effectively, stating, “A recall is the last line of defense... if the freaking companies can’t get it right – and these are not small companies – we are really in trouble.”

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• “This is nuts,” — Bill Marler, Food Safety Attorney

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• “A recall is the last line of defense, separating consumers from foodborne illness. But if the freaking companies can’t get it right – and these are not small companies – we are really in trouble,” — Sandra Eskin, CEO of Stop Foodborne Illness

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• “In a statement, a company spokesperson told CNN: “At TJX, product safety is very important to us and we prohibit the sale of recalled items in our stores.” — TJX Company Spokesperson

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• “You know, when CPSC recalls a product, it becomes illegal to sell that product.” — Peter Feldman, Acting Chairman of CPSC

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• “Issam Ahmed/AFP/ But rather than doing these spot checks, Yiannis said, we should be using technology to improve.” — Frank Yiannis, Former FDA Deputy Commissioner

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The ongoing issues surrounding the ByHeart infant formula recall highlight significant challenges in product safety compliance and regulatory oversight. As the FDA and CPSC work to enhance their monitoring efforts, the situation underscores the critical need for effective communication and technology in preventing the sale of recalled products.

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