Due to the multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula, during which product was found on store shelves weeks after the recall, the U.S. Food and Drug Administration (FDA) has issued an open letter to all food industry stakeholders describing firms’ legal obligations in the case of a food safety incident and outlining best practices for effective recalls. Separately, FDA sent warning letters to four major retailers—Target, Walmart, Kroger, and Albertsons—for failing to remove recalled ByHeart infant formula from store shelves.

Industry-Wide Letter: Strengthening Recall Systems

In its December 15, 2025 letter, FDA urged manufacturers, packers, distributors, importers, exporters, and retailers to review and improve recall procedures. The agency emphasized that recalls are a critical public health tool and that timeliness and effectiveness are especially vital when products intended for infants and young children are involved.

Key points from the letter include:

• Mandatory requirements for registered facilities: Facilities that are required to register under Section 415 of the Federal Food, Drug, and Cosmetic Act must maintain written recall plans detailing steps for direct consignee notification, public hazard alerts, effectiveness checks, and proper product disposition.
• Best practices for non-registered firms: While not legally required, FDA strongly encourages all firms, including retailers and distributors, to adopt written recall plans to ensure readiness and effectiveness
• Systemic deficiencies identified: FDA cited recent failures, including lack of recall awareness, incomplete removal of affected products, and restocking of returned recalled items, as evidence of industry-wide challenges.

The full letter to industry can be read here.

Retailer Warning Letters: Failure to Remove Recalled Formula

On December 12, 2025, FDA issued warning letters to Target, Walmart, Kroger, and Albertsons after investigators found recalled ByHeart infant formula on shelves weeks after the recall began. In some cases, recalled products were restocked or even offered at discounted prices following the expanded recall on November 11, 2025.

FDA conducted more than 4,000 retail checks nationwide and discovered recalled formula at more than 175 locations across 36 states, sometimes more than three weeks after the recall was initiated. FDA has not received reports of recalled formula remaining on shelves since November 26, 2025.

The retailers have 15 days to respond to FDA, detailing corrective actions or providing justification.

FDA’s warning letters to Target, Walmart, Kroger, and Albertsons can be found here.

Infant Botulism Outbreak Linked to ByHeart Formula

As of December 10, 2025, 51 infants across 19 states have contracted infant botulism with exposure to ByHeart formula; all were hospitalized, and no deaths have been reported.

Illness onset dates back to as early as December 2023, with the majority of cases occurring after August 2025. ByHeart has reported five positive product samples for Clostridium botulinum Type A.

All ByHeart formula products have been recalled nationwide.