FDA Issues Warning to Walmart and Target Over Dangerous Formula Sales

The U.S. Food and Drug Administration (FDA) has issued a critical warning to major retailers, including Target and Walmart, after discovering that recalled ByHeart infant formula products linked to a nationwide botulism outbreak were still available for sale. As of now, 51 infants across 19 states have been diagnosed with botulism, a serious and potentially fatal illness, following consumption of the affected formula.

The FDA’s warning letters, sent last Friday, highlighted that these retailers had failed to remove the recalled products from their shelves through at least November. Alarmingly, some stores had even displayed these products with promotional “Sale!” signs, which contradicted the intended recall. As part of their commitment to customer safety, Albertsons confirmed that they have removed all ByHeart infant formula products from their stores.

On November 11, 2023, ByHeart initiated a large-scale recall of all its Whole Nutrition Infant Formula products, which includes both cans and Anywhere Pack single-serve sticks. The Centers for Disease Control and Prevention (CDC) and the FDA have reported that the outbreak has resulted in hospitalizations of infants aged between 2 weeks and 9 months old.

Following a nationwide inspection covering over 4,000 stores, the FDA found recalled formula present in more than 175 locations across 36 states. Retailers have been given 15 days to respond to the FDA with plans for addressing the issue and preventing further violations.

In response to the FDA’s concerns, Walmart stated that they acted promptly to restrict sales and remove the affected product from their shelves and online platforms as soon as they were informed of the recall. ByHeart’s president and co-founder, Mia Funt, has emphasized the company’s dedication to consumer safety and is actively investigating the root cause of the contamination.

Botulism, the illness implicated in this outbreak, is rare but can be deadly, affecting the nervous system and potentially leading to breathing difficulties, paralysis, and death. Infants can develop infant botulism by ingesting spores of Clostridium botulinum, which produce a harmful toxin in the gut. The CDC urges caregivers to seek immediate medical attention if infants exhibit symptoms after consuming ByHeart products.

Since August 1, 2023, ByHeart has been offering full refunds for the recalled products purchased through their website and advises affected customers to contact either the company or the retailer from which they bought the formula for more information on refunds.