FDA Warns Major Retailers to Remove Recalled ByHeart Infant Formula

FDA warning letters sent to Target, Walmart, Albertsons and Kroger reveal that recalled ByHeart infant formula was still on store shelves, raising concerns about consumer safety.

FDA Warning Letters Sent to Major Retailers

On Friday, the Food and Drug Administration issued letters to the four largest U.S. grocery chains, stating that their stores nationwide were still selling recalled products linked to a deadly botulism outbreak. The letters were part of a multi‑state baby formula recall that began in August from the brand ByHeart. According to the Centers for Disease Control and Prevention, at least 51 infants across 19 states developed botulism after being fed ByHeart Whole Nutrition Infant Formula, and an investigation remains ongoing.

Each letter began with a stern reminder: “As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall.” The letters continued, “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 Details and Current Availability

Despite the recall, the FDA found that the products remained available for purchase on shelves through at least November, “well after the recall was initiated and expanded,” and despite multiple notifications. The agency documented that recalled products were still on shelves in at least 20 Target stores, and in one instance, single‑serve packs of the recalled formula were marked with a promotional “Sale!” sign. State and local partners reported several explanations offered by Target store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

The tainted formula also remained on shelves at Albertsons’ stores across 11 states, including Jewel‑Osco grocery stores; at Walmart, the products were on shelves across 21 states; and at Kroger‑owned stores across 10 states. The letter advises the stores to contact the FDA in writing within 15 days, detailing the steps taken to address the violations.

Retailer Responses

In a statement sent to NBC Chicago, Albertsons said ByHeart infant formula products have been removed from 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.” Target, Walmart and Kroger did not immediately respond to NBC Chicago’s request for comment.

Infant Botulism Overview

Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria. According to the FDA, symptoms 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 FDA warns that infant botulism can be fatal if not treated promptly.

Supply Chain and Market Impact

ByHeart’s formula accounts for less than 1 % of all infant formula sold in the U.S., and the FDA says the recall is not expected to affect nationwide supply or contribute to a formula shortage. 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

• Recalled ByHeart infant formula was still on shelves in Target, Walmart, Albertsons and Kroger stores through November.
• FDA letters demanded immediate removal and detailed corrective actions within 15 days.
• Albertsons confirmed removal; Target, Walmart and Kroger have not commented.
• 51 infants in 19 states have been diagnosed with botulism; 83 reports linked to infant formula.
• The recall is not expected to cause a nationwide formula shortage.

The FDA’s letters underscore the importance of swift action when a product recall is issued, and they highlight gaps in the current supply‑chain compliance that could put vulnerable infants at risk. Consumers are advised to check the expiration dates and lot numbers of infant formula products and to report any suspected cases of botulism to healthcare providers and the FDA.