1 In a move that highlights a significant lapse in consumer safety protocols, the agency revealed that these major chains continued to sell ByHeart Whole Nutrition Infant Formula for weeks after it was recalled due to a dangerous contamination risk.2 The warning letters, sent in mid-December 2025, admonish the corporations for failing to remove the potentially deadly product from theThe U.S. Food and Drug Administration (FDA) has issued a stern warning to some of the nation’s largest retailers, including Target, Walmart, Kroger, and Albertsons.ir shelves, placing infants at risk during a widening botulism outbreak.3
A Dangerous Oversight in the Supply Chain
The core of the issue stems from a failure to execute a critical product recall.4 ByHeart Inc. initiated a voluntary recall of its infant formula in early November 2025 after the product was linked to a multi-state outbreak of infant botulism.5 Despite being notified of the recall—and its subsequent expansion to include all ByHeart formula products—FDA investigators found the tainted formula readily available for purchase at retail locations across the country.6
The FDA’s investigation painted a concerning picture of negligence. Inspectors discovered the recalled formula on shelves at Walmart stores in 21 states and Target locations in 20 states.7 Perhaps most exhibiting was an incident in Arkansas, where a Target store was not only stocking the recalled formula but actively promoting it with a “Sale!” sign offering a $2.00 discount.8 This promotion occurred days after the retailer had been explicitly notified that the product was unsafe for consumption.9
The Health Risk: Infant Botulism
The stakes of this oversight are incredibly high. The recall was triggered because the formula was identified as the source of Clostridium botulinum, a bacterium that produces a toxin attacking the body’s nerves.10 Infant botulism is a rare but serious illness that can lead to muscle weakness, difficulty feeding, and even respiratory failure.11
According to the Centers for Disease Control and Prevention (CDC), the outbreak associated with this formula has already sickened at least 51 infants across 19 states.12 All affected infants required hospitalization to treat the severe symptoms, which can include a weak cry, loss of head control, and constipation. The FDA has emphasized that for vulnerable populations like infants, there is zero margin for error when it comes to food safety.
Breakdown of Retailer Violations
The following table details the specific findings cited by the FDA regarding the sale of the recalled ByHeart formula:
| Retailer | States Where Recalled Product Was Found | Notable Incidents Cited by FDA |
| Target | 20 States | Recalled product found on “Sale” in Arkansas; product sold in New Hampshire despite electronic locks. |
| Walmart | 21 States | Product found on shelves for two weeks post-recall; staff cited “confusion” over lot numbers. |
| Kroger | 10 States | Recalled formula remained on shelves in affiliated stores like King Soopers and Smith’s. |
| Albertsons | 11 States | Product available in stores (including Safeway and Acme) well after recall notification. |
FDA Threatens Legal Action
The FDA’s letters were not merely informational; they served as a prelude to potential legal consequences. The agency criticized the retailers for failing to provide adequate responses to previous email inquiries regarding their recall procedures.13 The letters explicitly stated that failure to promptly correct these violations could result in “seizure and injunction.”
This aggressive stance signals a shift in how the FDA is policing the retail end of the supply chain. While manufacturers are typically the focus of recalls, this event underscores that retailers bear an equal responsibility to ensure unsafe products do not reach the consumer. The agency noted that despite electronic systems intended to block sales of recalled items, “systematic failures” allowed the formula to leave stores in the hands of unsuspecting parents.14
Retailer Responses and Consumer Action
In the wake of the public warning, the retailers have begun to respond. Walmart representatives stated that they have moved to issue sales restrictions and remove the products, claiming they take “all reports of inaction seriously.”15 Target has previously mentioned employing electronic blocks at the register to prevent the sale of recalled items, though the FDA’s findings suggest these safeguards were either bypassed or ineffective in certain locations.16
Parents and caregivers are urged to be vigilant. If you possess any ByHeart Whole Nutrition Infant Formula, do not use it. The recall covers all lots, regardless of the expiration date.17 Consumers should discard the product immediately or return it to the point of purchase for a refund. If an infant has consumed this formula and shows signs of lethargy or poor feeding, seek emergency medical care immediately.
Frequently Asked Questions
Q1: Which specific formula brands are affected by this alert?
A: The alert specifically concerns ByHeart Whole Nutrition Infant Formula. The recall includes all cans and single-serve “anywhere pack” sticks, regardless of the lot number or expiration date.18
Q2: What should I do if I bought the formula from Target or Walmart recently?
A: Stop using the formula immediately. You should return the product to the store for a full refund. If your baby has consumed it, monitor them closely for symptoms of botulism such as muscle weakness or difficulty swallowing.
Q3: Can I tell if the formula is contaminated by looking at it?
A: No. Clostridium botulinum spores cannot be seen, smelled, or tasted. The formula may look and smell completely normal even if it is contaminated with the bacteria.
Disclaimer
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