Target, Walmart and Other Retailers Reacted Too Slowly to ByHeart Infant Formula Recall: FDA

Health officials say potentially contaminated ByHeart formula remained on store shelves for weeks after the recall, exposing systemic failures in protocols.

The FDA has issued warning letters to Walmart, Target, Kroger and Albertsons after investigators found recalled ByHeart infant formula still being sold days and, in some cases weeks, after retailers were notified the product was linked to a nationwide infant botulism outbreak.

Federal and state health officials first began tracking an infant botulism outbreak in early November, after reports emerged of newborns being hospitalized with botulism following consumption of ByHeart formula.

On November 8, the FDA announced that ByHeart had issued a voluntary recall of certain batches of its Whole Nutrition Infant Formula after federal health officials reported that at least 13 infants across 10 states had developed botulism infections believed to be linked to the product. By November 11, the agency expanded the action to include all unexpired ByHeart Whole Nutrition Infant Formula cans and single-serve Anywhere Pack products sold nationwide.

Retailers were formally notified of both the initial recall and the expansion, as regulators sought to prevent further exposure while investigators worked to determine the source of the contamination.

However, in a ByHeart botulism outbreak update issued on December 10, federal health officials reported that illness counts had grown to 51 infants across 19 states, with cases dating back to December 2023 and continuing through December 1, 2025. All affected infants were hospitalized and treated with BabyBIG, the antitoxin used to counteract botulinum toxin.

As awareness of the outbreak became public, a series of ByHeart infant botulism lawsuits began to be filed by parents whose infants were diagnosed with the illness after consuming recalled formula. The claims allege the company allowed contaminated formula to enter the marketplace and failed to prevent exposure to Clostridium botulinum, resulting in severe illness, emergency hospitalization and lasting health concerns.

Recalled ByHeart Formula Remained on Store Shelves for Weeks

Following the expansion of the outbreak and recall, the FDA launched a nationwide effort to determine whether recalled ByHeart formula had been successfully removed from store shelves. According to the agency, thousands of retail inspections were conducted in coordination with state and local partners to verify recall compliance.

That effort led to the issuance of formal warning letters on December 12 to Walmart, Target, Kroger and Albertsons, after inspectors repeatedly found recalled ByHeart formula still being offered for sale well after retailers had received written notice of the recall and its expansion. The FDA said the findings raised serious concerns about recall effectiveness for a product intended for infants.

In its warning letter to Walmart, the FDA stated that recalled formula remained available for purchase in stores across more than 20 states between November 12 and November 26, despite the retailer having received recall notifications on November 8 and November 11. Investigators reported instances where store employees were unaware of the recall, confused about which products were affected, or had restocked recalled formula after the recall had already taken effect.

The FDA made similar findings in its warning letter to Target, stating that recalled ByHeart formula was found on shelves in at least 20 states days after the recall expansion. In at least one location, inspectors documented recalled formula being sold with promotional “sale” pricing, indicating the product was not only left on shelves but actively offered for purchase.

According to the warning letter sent to Kroger, recalled formula continued to be available at Kroger-owned stores, including King Soopers and Smith’s locations, across at least 10 states. FDA investigators said store personnel cited lack of recall awareness, incomplete removal efforts and confusion over product identification as reasons the formula remained available.

The warning letter to Albertsons detailed similar violations, with recalled formula found at Albertsons-affiliated banners such as Safeway, Jewel-Osco, Acme and Shaw’s across at least 11 states. The FDA said it conducted multiple follow-ups with the company but did not receive documentation demonstrating that effective, nationwide corrective actions had been implemented.

Across all four warning letters, the FDA cited violations of the Federal Food, Drug and Cosmetic Act, which prohibits the distribution of adulterated food in interstate commerce, and emphasized that retailers are legally responsible for promptly removing recalled products from sale. The agency warned that failure to correct the violations could result in enforcement actions, including product seizures or court-ordered injunctions. Each retailer was given 15 working days to submit a written response detailing corrective actions and steps taken to prevent future recall failures.

In addition to the warning letters, the FDA released broader guidance calling on food industry leaders to strengthen recall compliance and improve recall effectiveness across the supply chain. The agency said the ByHeart outbreak exposed systemic weaknesses in how recalls are communicated and carried out, particularly at the retail level.

The FDA urged manufacturers, distributors and retailers to improve internal communication systems, employee training and product tracking to ensure recalled items are immediately identified and removed. The agency also emphasized the need for clearer accountability throughout the supply chain when products intended for vulnerable populations, such as infants, are involved.

ByHeart Infant Botulism Lawsuits

Following the recalls, multiple lawsuits have been filed against ByHeart by parents whose infants were diagnosed with botulism after consuming the recalled formula. These claims allege the company allowed contaminated infant formula to enter the marketplace, exposing babies to Clostridium botulinum and causing serious, potentially life-threatening illness.

Several of the lawsuits involve parents whose children required hospitalization after developing symptoms of infant botulism, including muscle weakness, feeding difficulties and respiratory distress. The complaints allege the manufacturer failed to adequately test, monitor or safeguard its products before they were sold to consumers.

In addition to personal injury claims, a ByHeart class action lawsuit was also filed on behalf of parents who purchased the recalled formula, regardless of whether their children became ill. That lawsuit alleges consumers were misled by claims that the formula was made with “certified clean ingredients,” and argues parents paid a premium for a product that was later recalled due to contamination concerns.

Parents who believe their children developed botulism after consuming ByHeart formula may be eligible to file a claim. To find out if you qualify, submit information about your potential case for review.

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