In late November 2025, FDA inspectors checked more than 4,000 stores across America and discovered a frightening problem. Recalled ByHeart baby formula still sat on shelves weeks after officials warned parents to stop using it. Some stores even put the dangerous product on sale with bright discount stickers. The formula caused infant botulism, a serious illness that sent 51 babies in 19 states to the hospital. Doctors treated every infant who drank the contaminated formula, though thankfully, no babies died. Tests found Clostridium botulinum bacteria in the formula, which creates a powerful toxin that can paralyze breathing muscles in infants.
ByHeart started selling formula in March 2022 and controlled less than 1% of the American market. The company already had safety problems before this outbreak. In August 2023, the FDA sent ByHeart a warning letter about disgusting conditions at their Pennsylvania factory. Inspectors found mold, dead insects, and water leaks. The company had already recalled the formula in 2022 due to bacterial contamination. California health officials noticed an increase in botulism cases in August 2025 and began investigating. By November, they traced the outbreak to the ByHeart formula. The company recalled two batches on November 8, then expanded the recall on November 11 to include all ByHeart formula products.
Four Major Chains Failed to Remove Dangerous Products
The FDA sent official warning letters to Walmart, Target, Kroger, and Albertsons on December 12, 2025. The agency accused these retailers of breaking federal law by continuing to sell contaminated formula after receiving recall notices. Despite being notified on November 8 and November 11, stores continued to sell the formula from November 12 through November 26. Inspectors found recalled products in more than 175 stores across 36 states. The FDA stated that retailers left formula available “well after the recall was initiated,” calling it a “concerning problem with recall effectiveness.”
Walmart performed the worst among the four chains. The company’s stores in 21 states sold recalled formula for up to 18 days after Walmart received the recall notice. Target stores in more than 20 states kept the product available for 8 to 12 days after the recall was announced. Kroger and Albertsons stores in 10 and 11 states, respectively, still had recalled formula on shelves through at least November 19. Parents in Illinois, Michigan, Pennsylvania, Texas, and California purchased ByHeart formula despite health officials’ warnings to stop.
An Arkansas Target became the most obvious example of the problem. FDA staff found ByHeart single-serve packets on display under a big “Sale!” sign offering a $2 discount. The store started this promotion five days after the November 11 expanded recall, which warned that all ByHeart products might be contaminated. The discounted packets stayed on shelves until November 22. Store workers told federal inspectors they didn’t know which batch codes were recalled, hadn’t seen the recall notices, or couldn’t find the formula stored in back rooms. Some stores accidentally put returned products back on shelves after customers brought them back.
Regulators Demand Changes and Families Sue
FDA Commissioner Dr. Marty Makary said, “Food safety is a collective responsibility,” and ordered the four retailers to submit detailed plans within 15 working days explaining how they would improve their systems. Some critics blamed the FDA itself for delays. Steven Mandernach, who leads the Association of Food and Drug Officials, pointed out that the FDA took nearly a week after the November 8 recall to provide state regulators with complete product lists, making it harder for them to check store inventory.
The CDC expanded its investigation on December 10, 2025, examining any infant with botulism who had consumed ByHeart formula at any time since March 2022. This review identified 10 additional confirmed cases dating back to December 2023, indicating that contamination problems persisted for three years. ByHeart’s testing found the dangerous bacteria in three different batches, indicating that contamination was not a one-time accident.
Families began suing ByHeart for selling defective formula despite being aware of the factory’s problems. The lawsuits ask for money to cover hospital bills, including BabyBIG treatment that costs tens of thousands of dollars, plus compensation for emotional suffering. By late December 2025, inspectors hadn’t found recalled formula in stores since November 26, and no new babies got sick after December 1. The outbreak revealed a troubling reality: if four major chains struggled to recall a tiny brand, a crisis involving a popular product could overwhelm the entire system.
Sources:
CNN, FDA sends warning letters to major retailers for selling recalled baby formula, December 15, 2025
FDA.gov, Outbreak Investigation of Infant Botulism: Infant Formula, December 16, 2025
FDA Warning Letters, Walmart Inc. MARCS-CMS 720400 and Target Corporation 720399, December 12, 2025
Food Safety News, FDA warns retailers who failed to pull recalled ByHeart formula, December 9, 2025
CBS News, FDA warns 4 major retailers about failure to quickly stop selling recalled baby formula, December 16, 2025
FDA Press Release, FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak, December 14, 2025