Federal regulators slapped four of the nation’s biggest retailers with warning letters after investigators found recalled ByHeart baby formula tied to a botulism outbreak still sitting on store shelves weeks after the recall.
The letters, issued Friday by the Food and Drug Administration’s Human Foods Program, accused Walmart, Target, Kroger and Albertsons of continuing to sell or offer for sale “adulterated” infant formula linked to an outbreak that has sickened 51 babies across 19 states, despite repeated recall notices and follow-up warnings from regulators.
The FDA said that the ByHeart Whole Nutrition Infant Formula was the source of the outbreak, which involves infant botulism, a rare but potentially fatal illness caused by exposure to Clostridium botulinum spores — a dormant, highly resistant survival form of the bacterium Clostridium botulinum.
All 51 infants ranging in age from 16 to 264 days old identified in the outbreak were fed ByHeart formula before becoming ill, according to the agency.
ByHeart initiated a voluntary recall of certain lots of its formula on Nov. 8, then expanded the recall on Nov. 11 to include all ByHeart infant formula products, including cans and single-serve “anywhere pack” sticks.
But FDA inspectors and state health officials later found recalled formula still for sale at stores operated by the four companies in dozens of locations across the country, the warning letters state.
At Walmart, regulators confirmed recalled ByHeart formula remained on shelves at stores in 21 states from Nov. 12 through Nov. 26, well after the recall had been expanded.
FDA officials said Walmart failed to demonstrate that it had taken corrective action despite multiple follow-up emails and a call with the company’s leadership.
Target faced similar findings. FDA investigators determined recalled formula was available at Target locations in 20 states from Nov. 12 through Nov. 20, even though the company said it had electronically blocked the affected products.
Kroger was cited for keeping recalled ByHeart formula on shelves at stores in 10 states, including Kroger, King Soopers and Smith’s locations, between Nov. 12 and Nov. 19.
Albertsons was flagged for similar failures at stores across 11 states, including subsidiaries Safeway, Jewel-Osco, Acme, Star Market and Shaw’s.
FDA officials said recalled formula remained available for purchase days after Albertsons was notified of both the initial recall and the expanded recall.
“At Albertsons Companies, we are committed to the health and safety of our customers,” a company rep told The Post in an emailed statement.
“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.”
Infant botulism occurs when babies ingest spores that grow in the immature gut and produce a dangerous toxin.
Early symptoms often include constipation, poor feeding, loss of head control and difficulty swallowing. The condition can progress to respiratory failure.
The FDA said symptoms can take weeks to appear after exposure, complicating efforts to identify contaminated products quickly.
As part of the ongoing investigation, the FDA, CDC and state partners are continuing to analyze unopened formula samples.
Officials cautioned that negative test results do not rule out contamination, given the scientific challenges of detecting the bacteria.
The FDA warned all four retailers that failure to correct the violations could result in seizure, injunction or other legal action. Each company has been given 15 working days to respond with a plan to prevent recalled products from being received or sold in the future.
The warning letters make clear the agency considers retailers responsible for removing dangerous products once they are notified of a recall, calling immediate removal “essential” to preventing further exposure.
ByHeart has recalled all of its infant formula products nationwide. The investigation into the botulism outbreak remains ongoing.
The Post has sought comment from ByHeart, Kroger, Walmart and Target.
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