Formula tied to unprecedented infant botulism outbreak
-
FDA says major retailers continued selling recalled infant formula linked to a first-ever U.S. botulism outbreak
-
ByHeart formula has been tied to at least 51 suspected or confirmed infant botulism cases in 19 states
-
Agency warns companies could face seizures or injunctions if failures arent corrected
FDA issues stern warning letters to retailers
The U.S. Food and Drug Administration has sent warning letters to Walmart, Target, Kroger and Albertsons after investigators found the retailers continued selling recalled baby formula linked to an outbreak of infant botulism.
In letters released Monday, the FDA said the companies failed to promptly remove ByHeart Whole Nutrition Infant Formula from store shelves even after the product was recalled in November due to its connection to the outbreak.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, the FDA warned.
The Centers for Disease Control and Prevention has described the outbreak as unprecedented, calling it the first-ever infant botulism outbreak identified in the United States.
As of Dec. 10, the formula had been linked to at least 51 suspected or confirmed cases of infant botulism across 19 states, according to the FDA letters. The CDC determined the formula was the source of the outbreak, the agency said.
Major retailers were notified of the initial recall on Nov. 8, and ByHeart expanded the recall to all of its products on Nov. 11.
FDA says retailers failed to act or explain how they did
Despite the recalls, FDA investigators found the formula remained for sale well afterward at multiple chains.
Target continued selling the recalled formula in stores across 20 states well after the recall was initiated and subsequently expanded, the FDA said, adding that the product was still displayed with promotional discount signage more than two weeks after the first recall.
Walmart continued selling the formula across 21 states, while Kroger and some of its affiliate stores sold it in 10 states. Albertsons stores continued sales in 11 states, according to the FDA.
The agency also criticized all four retailers for failing to provide evidence of corrective actions, despite follow-up calls and repeated email requests.
As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall, the FDA wrote in each letter.
Store brands named in warning letters
The FDA said multiple grocery banners owned by the companies continued offering the formula after the recall, including:
-
Albertsons-owned stores: Star Market, Jewel-Osco, Acme, Safeway and Shaws
-
Kroger-owned stores: King Soopers and Smiths Food and Drug
Why infant botulism is dangerous
Infant botulism occurs when babies ingest spores of Clostridium botulinum bacteria, which can then produce toxins in the large intestine, according to the CDC. While rare, the condition can be fatal.
Symptoms include poor feeding, loss of head control, trouble swallowing or breathing, decreased facial expression, and a weak or altered cry. Symptoms may take days or even weeks to appear.
The CDC has urged parents and caregivers to seek immediate medical care if an infant consumed the recalled formula and shows any of these signs.
Posted: 2025-12-16 16:01:42















