FDA warns recalled ByHeart formula remains on shelves at Target, Walmart, other retailers
The Food and Drug Administration has issued warning letters to Target, Walmart, Albertsons and Kroger, saying their stores nationwide were still selling recalled products linked to a deadly botulism outbreak.
The warning letters are part of a major, multi-state baby formula recall initiated 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.
The letters, sent Friday, stated 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.”
According to the FDA, the recalled products remained on shelves in at least 20 Target stores. In one instance, single-serve packs of the recalled formula was 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.
The FDA also said the tainted formula remained on shelves at Albertsons’ stores across 11 states, including Jewel-Osco grocery stores. At Walmart, the products were on shelves across 21 states, the FDA said, 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.
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.
What Is Infant Botulism?
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
- Respiratory difficulty or arrest
The FDA warns that infant botulism can be fatal if not treated promptly.
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.
Are Other Brands Involved?
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.
