Fulginiti Law Warns Parents After FDA Flags Major Retailers for Selling Recalled Infant Formula Linked to Nationwide Botulism Outbreak

PHILADELPHIA, Dec. 16, 2025 /PRNewswire/ -- Fulginiti Law is urging parents and caregivers to immediately check any ByHeart Whole Nutrition Infant Formula in their homes after the U.S. Food and Drug Administration issued warning letters on Monday to four of the nation's largest retailers—Walmart, Target, Kroger, and Albertsons—for continuing to sell products that had already been recalled due to a dangerous link to infant botulism.

According to the FDA, the recalled formula remained on shelves after retailers were notified in November, exposing families to a potentially fatal hazard. Infant botulism, caused by ingestion of Clostridium botulinum spores, can lead to constipation, poor feeding, loss of head control, difficulty swallowing, and in severe cases, respiratory failure. The CDC reports 51 infants across 19 states have already been sickened, ranging in age from just two weeks old to nearly nine months.

ByHeart initially recalled select lots of its formula before expanding the action to all infant formula products—including cans and single-serve stick packs—only three days later. FDA inspectors discovered recalled products in Walmart locations across 21 states and Target stores in 20 states; in some cases, promotional discounts were still being offered on recalled formula. Employees reportedly cited confusion, lack of awareness, and failure to remove all affected items as reasons the products remained available for purchase.

"This is an unacceptable breakdown in retail safety practices," said Ken Fulginiti, Esq., founder of Fulginiti Law and a leading product-liability attorney. "These products were recalled because they posed a clear danger to infants. Yet they remained on store shelves where unsuspecting parents could buy them. This is exactly why we maintain the Fulginiti Law Recall Field Report, because these recalls can be so dangerous and potentially fatal."

Fulginiti emphasized that recalls are only effective when every link in the chain, from manufacturers to regulators to retailers, takes immediate and thorough action. "Parents shouldn't have to wonder whether a recalled baby formula might still be sitting on a store shelf. When systems fail, children pay the price."

The FDA has given all four retailers 15 working days to explain how they will prevent similar violations, warning that failure to act could result in legal enforcement including product seizures.

Fulginiti Law encourages any parent whose child consumed ByHeart infant formula and experienced concerning symptoms, including poor feeding, constipation, weakened muscle control, or breathing difficulties, to seek medical attention immediately and preserve all product packaging. The firm is actively reviewing potential claims on behalf of affected families.

About Fulginiti Law

Fulginiti Law is a premier Philadelphia-based firm dedicated to representing victims of catastrophic injury. With over 35 years of experience, the firm's founder has built a remarkable track record in complex cases involving product defects, premises liability, construction accidents, and trucking collisions, among other-type cases..

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SOURCE Fulginiti Law