FDA Criticizes ByHeart’s Slow Response to Baby Formula Recall

The U.S. Food and Drug Administration (FDA) has criticized ByHeart for its delayed response to a serious baby formula recall due to contamination. This recall, triggered by a botulism outbreak, has affected over 50 infants across 19 states. The FDA sent warning letters to several major retailers, including Walmart, Target, Kroger, and Albertsons, highlighting their failure to promptly remove the implicated formula from their shelves.

Contaminated Formula and Retailer Response

On November 11, 2025, the FDA issued a recall for all ByHeart infant formula products linked to the outbreak. However, stores continued selling the formula for days after the recall was announced. Federal officials expressed concern that these retailers did not act quickly enough to protect consumers.

ByHeart formula was reportedly available at Target locations in 20 states even after the recall. In one instance, a Target store in New Hampshire sold the product on November 16, despite a sales block being in place. During the same week, Target in Arkansas offered discounts on ByHeart formula.

The FDA found the formula in Walmart stores across 21 states from November 12 to November 26. In addition, Albertsons had the product available in 11 states, and Kroger in 10 states, both from November 12 to November 19.

FDA’s Warning Letters

The FDA’s warning letters were sent on December 12, demanding companies show evidence of corrective actions taken in response to the recall. The stores have 15 working days to respond to these letters.

Statements from Retailers

• Walmart: The company insisted that it swiftly implemented a sales restriction after the recall.
• Albertsons: Representatives stated they collaborated with suppliers and authorities to remove the dangerous product from their stores.

All infants affected by this outbreak have required hospitalization and intravenous medication to combat the botulism threat. In response to the ongoing health crisis, the Centers for Disease Control and Prevention (CDC) expanded the investigation to include any infants treated for botulism after consuming ByHeart formula since its introduction in 2023.

Concerns Over Urgency in Recall Response

Critics, including Steven Mandernach, executive director of the Association of Food and Drug Officials, voiced frustration about the slow dissemination of information regarding the recall. The FDA did not fully share product identification until November 14, nearly a week after the initial recall announcement on November 8. Mandernach remarked on the lack of urgency in ensuring that potentially harmful products were removed from the market, particularly because vulnerable infants rely on these formulas for nutrition.