The US Food and Drug Administration has issued warning letters to several major national retailers after determining that recalled infant formula products remained available for sale despite prior notification of the recall. The enforcement action highlights FDA’s expectations for retail-level compliance during public health recalls and underscores the regulatory responsibilities of distributors and sellers, not just manufacturers.
According to FDA correspondence dated December 12, the agency cited Walmart, Target, Kroger, and Albertsons for continuing to sell ByHeart Whole Nutrition Infant Formula after a nationwide recall was announced in November. The recalled products were linked to an outbreak of infant botulism, a rare but serious illness caused by exposure to Clostridium botulinum spores.
Public Health Risk and Scope of the Outbreak
Infant botulism occurs when spores of C. botulinum are ingested and produce toxins in an infant’s immature digestive system. Symptoms can include constipation, poor feeding, loss of head control, difficulty swallowing, and in severe cases, respiratory distress.
As of early December, the Centers for Disease Control and Prevention reported 51 confirmed cases across 19 states, affecting infants ranging from approximately two weeks to nine months of age. While investigations into the source of contamination are ongoing, FDA has emphasized that prompt removal of recalled products is essential to limit exposure and protect vulnerable populations.
Recall Expansion and Retail Compliance Failures
ByHeart initially recalled specific lots of its infant formula before expanding the recall days later to include all infant formula products, including cans and single-serve stick packs. Despite these actions, FDA inspections found recalled products still on store shelves weeks after retailers had been notified.
FDA documented recalled formula available for sale at Walmart locations across 21 states and at Target locations across 20 states. In at least one instance, Target was found offering a promotional discount on the recalled product during the recall period.
Retail staff reportedly cited multiple reasons for the continued availability of recalled products, including lack of awareness, confusion over which products were affected, and incomplete removal from shelves. FDA noted that such breakdowns demonstrate weaknesses in recall execution and internal communication systems.
Regulatory Expectations for Retailers
FDA has given the cited retailers 15 working days to respond with corrective actions and explain how they will prevent similar violations in the future. The agency warned that failure to adequately address the issues could result in further enforcement, including product seizure.
The action reinforces that retailers play a critical role in the food and consumer product safety ecosystem. Once notified of a recall, companies are expected to act promptly and comprehensively, with systems in place to ensure recall notices are clearly communicated and executed across all locations.
Key Takeaways for Industry
This enforcement action serves as a reminder that recall compliance extends beyond manufacturers. Distributors and retailers must maintain robust recall management processes, clear product traceability, and effective internal controls to ensure rapid response when public health risks arise.
How EMMA International Supports Recall and Compliance Readiness
At EMMA International, we support organizations across the life sciences and consumer health supply chain with recall readiness planning, regulatory compliance assessments, quality system strengthening, and post-market risk management. Our teams help companies implement effective processes to respond to recalls, regulatory inspections, and enforcement actions with confidence.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. Warning letters issued to retailers regarding recalled infant formula. December 2025.
Centers for Disease Control and Prevention. Infant botulism surveillance and outbreak updates. 2025.
Reuters. U.S. FDA sends warning letters to Walmart, Target for selling recalled baby formula. December 15, 2025.
