In a startling development, the Food and Drug Administration sent warning letters to four of the country’s biggest grocery chains, alleging that recalled ByHeart infant formula was still being sold across their shelves.
FDA Warning Letters
The letters, sent Friday, warned Target, Walmart, Albertsons and Kroger that their stores nationwide were still selling recalled products linked to a deadly botulism outbreak. The letters say that despite the recall, the products remained available for purchase on shelves through at least November, and “well after the recall was initiated and expanded,” and despite multiple notifications.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” each of the letters said. “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
The recall was initiated in August. At least 51 infants across 19 states developed botulism after being fed ByHeart Whole Nutrition Infant Formula, and the investigation remains ongoing. The recalled products remained on shelves in at least 20 Target stores. In one instance, single-serve packs of the recalled formula were marked with a promotional “Sale!” sign, the FDA said. 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 letter said. At Albertsons, the tainted formula remained on shelves 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.
Company Responses
Albertsons said in a statement sent to NBC Chicago: “At Albertsons Companies, we are committed to the health and safety of our customers,” and that they 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.
Impact on Formula Supply
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.
Infant Botulism Symptoms
- Constipation
- Poor feeding
- Drooping eyelids
- Sluggish pupils
- Low muscle tone
- Difficulty sucking or swallowing
- Weak or altered cry
- Generalized weakness
- Respiratory difficulty or arrest
The FDA warns that infant botulism can be fatal if not treated promptly.
Ongoing Investigation
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 issued warning letters to Target, Walmart, Albertsons and Kroger after recalling ByHeart infant formula.
- Recalled products were still on shelves in multiple states, prompting store violations.
- Albertsons removed the formula and confirmed procedures to address recalls; other chains have not yet responded.
Closing
The FDA’s letters underscore the importance of swift action when a product recall is announced. While the recalled ByHeart formula represents a small fraction of the U.S. infant formula market, the potential health risks to infants and the widespread distribution of the product across major retailers make the situation a serious public health concern.
