FDA Warns Major Retailers For Selling Recalled Baby Formula Linked To Infant Botulism Outbreak

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(RTTNews) - The U.S. Food and Drug Administration has issued warning letters to four major retailers for continuing to sell baby formula tied to a nationwide outbreak of bacterial illness in infants, despite the products having been recalled, according to the regulator's website.

In November 2025, the FDA and the Centers for Disease Control and Prevention began investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.

As of December 10, 2025, 51 suspected or confirmed cases across 19 states had been reported among infants aged 16 to 264 days, with evidence identifying the formula as the source. The presence of Clostridium botulinum rendered the product adulterated under federal law, prompting ByHeart Inc. to voluntarily recall certain lots on November 8, 2025.

ByHeart initially recalled select lots of its formula and expanded the recall three days later to include all of its infant formula products, covering both cans and single-serve stick packs.

Despite the recall, the FDA said the product remained on shelves at Walmart stores in 21 states, Kroger-owned locations in 10 states, Albertsons stores in 11 states, and Target locations in 20 states during mid-to-late November 2025, days after each retailer had been notified of the recall and its expansion.

Infant botulism occurs when babies ingest spores of Clostridium botulinum, which can grow in their immature digestive systems and produce toxin. Symptoms include constipation, poor feeding, loss of head control, and difficulty swallowing. In severe cases, infants can develop breathing problems.