FDA Warns Major Retailers for Selling Recalled ByHeart Formula Linked to Botulism Outbreak

FDA letters sent on Friday to Target, Walmart, Albertsons and Kroger revealed that stores across the country were still offering recalled infant formula that was tied to a deadly botulism outbreak.

FDA Warning Letters

The letters, part of a broader enforcement action, cited the fact that recalled products remained on shelves through at least November, long after the recall was expanded. Each letter urged the retailers to act swiftly: “As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” the FDA wrote. The agency added, “Once your firm has been made aware of a recall or potential safety issue, you should take action to immediately remove the affected product from distribution and sale, cease all further shipment or use, and implement all necessary measures to prevent further exposure to consumers or downstream distribution.”

Recall Background

The recall began in August when ByHeart, a brand that sells infant formula, voluntarily pulled its Whole Nutrition Infant Formula from the market after a series of botulism cases. The Centers for Disease Control and Prevention reported that at least 51 infants in 19 states developed botulism after being fed the recalled formula. An investigation into the outbreak is still ongoing.

Target’s Findings

According to the FDA, the tainted formula was found in at least 20 Target stores nationwide. In one example, single‑serve packs were marked with a promotional “Sale!” sign. State and local partners noted several explanations from Target associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion about which specific lots were affected, failure to remove all impacted product, and stocking items that arrived after the recall notification.

Walmart, Albertsons and Kroger

The agency also identified that the recalled formula was still on shelves at Albertsons stores in 11 states, including Jewel‑Osco grocery outlets. Walmart had the product available across 21 states, while Kroger‑owned stores carried it in 10 states. Each letter directed the retailers to contact the FDA in writing within 15 days, outlining the steps taken to correct the violations.

Albertsons Response

In a statement sent to NBC Chicago, Albertsons confirmed that ByHeart infant formula products had been removed from its store shelves. “At Albertsons Companies, we are committed to the health and safety of our customers,” the statement read. “We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items and communicate guidance to customers.”

No Immediate Comments from Target, Walmart and Kroger

Target, Walmart and Kroger did not respond to NBC Chicago’s request for comment at the time of reporting. Their silence does not alter the FDA’s findings that the recalled products were still available for purchase.

Infant Botulism Overview

Infant botulism is a rare but severe illness caused by the Clostridium botulinum bacteria. The FDA lists symptoms that may include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking or swallowing, weak or altered cry, generalized weakness, and respiratory difficulty or arrest. The agency warns that the disease can be fatal if not treated promptly.

Impact on Formula Supply

ByHeart’s formula represents less than 1% of all infant formula sold in the United States. The FDA states that the recall is not expected to affect nationwide supply or contribute to a formula shortage.

Other Brands

Since August, the FDA has received 83 reports of botulism potentially tied to infant formula. NBC Chicago has asked the agency for the names of other brands involved, but no additional information has been released.

Key Takeaways

• FDA letters highlighted that recalled ByHeart formula remained on shelves in Target, Walmart, Albertsons and Kroger stores through November.
• At least 51 infants in 19 states developed botulism after consuming the recalled formula.
• Albertsons confirmed removal of the product, while Target, Walmart and Kroger have not yet responded to inquiries.

The FDA’s enforcement action underscores the importance of swift compliance with recall notices to protect vulnerable consumers.