FDA sends warning letters to major retailers for selling recalled formula linked to infant botulism outbreak
By Jen Christensen, CNN
(CNN) — The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism outbreak.
The FDA said it communicated with the retailers about the recall repeatedly, even sending several emails requesting plans of action to comply with the recall, but none of the companies responded to the request.
“Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food,” FDA Commissioner Dr. Marty Makary said in a statement.
The recall of ByHeart infant formula products started November 8 and was expanded three days later to include all ByHeart Whole Nutrition Infant Formula products. As of December 10, 51 children from 19 states have had suspected or confirmed cases of infant botulism after confirmed exposure to these products. All 51 have been hospitalized, but no deaths have been reported. The outbreak investigation remains ongoing.
Infant botulism is a rare but potentially deadly infection that can happen after a baby ingests Clostridium botulinum bacteria spores. The bacteria then colonize the intestinal tract and produce neurotoxins that can lead to constipation, weakness, breathing problems and even respiratory arrest. An infant with botulism can also stop feeding well, have problems with swallowing and lose control of their head. In a typical year, fewer than 200 cases are reported in the US.
ByHeart said in a letter to parents last month that it will “continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain.”
The FDA said Monday that it sent warning letters last week to Target; Walmart; Kroger stores, including King Soopers and Smiths; and Albertsons stores, including Star Market, Jewel-Osco, Acme, Safeway and Shaw’s. Workers from the agency and state and local partners found the recalled products on shelves in “multiple locations across multiple states,” in one case three weeks after stores were sent a written recall notification.
The FDA said it communicated with the retailers about the recall repeatedly, even sending several emails requesting plans of action to comply with the recall, but none of the companies responded to the request.
Checking stores more than 4,000 times, inspectors found the recalled products in over 175 locations across 36 states, according to the FDA, although the agency says it has not received reports of recalled formula being on store shelves since November 26.
In the case of one Target store, not only was ByHeart formula still on the shelf after the products were recalled, investigators found ByHeart Whole Nutrition Infant Formula single-serve “anywhere pack” sticks for sale at a $2 discount, according to the FDA letter.
Retail workers gave various reasons why the recalled product was still for sale. Some associates said they had general stocking issues, were unaware of the recall or were confused about what lots had been recalled, despite the written notifications.
“The health and safety of our customers and members is always a top priority,” a Walmart spokesperson told CNN. “When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online. We take all reports of inaction seriously and will respond to the letter.”
Albertsons Companies said in a statement, “we are committed to the health and safety of our customers. 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. ByHeart infant formula products have been removed from our store shelves.”
Target and Kroger did not immediately respond to a request for comment.
The FDA gave the companies 15 working days to address the steps they’ve taken to address the problem, or they could face legal action.
It’s not the first time there has been a problem with stores complying with recalls, the FDA says. In 2023, after a recall of WanaBana apple cinnamon fruit puree pouches over concerns about lead contamination, the agency sent a similar warning letter to a retailer that failed to remove the products.
The-CNN-Wire
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