Target, other retailers hit with warning letter for selling recalled formula

Four major retailers failed to pull ByHeart infant formula from its store shelves following a recall, according to the agency’s letters. The formula has been linked to an outbreak of botulism.

The Minnesota Star Tribune
December 16, 2025 at 6:23PM
The FDA has issued a warning to several retailers, including Target and Walmart, for selling ByHeart formula after a recall was issued following a nationwide outbreak of infant botulism. (Cheyanne Mumphrey/The Associated Press)

Major U.S. retailers, including Walmart and Minneapolis-based Target, have been hit with warning letters from the U.S. Food and Drug Administration for continuing to sell baby formula that was recalled amid a widespread outbreak of infant botulism.

In one case, regulators said a Target store in Arkansas was offering a discount on ByHeart Whole Nutrition Infant Formula five days after it was recalled. So far, three infants in Minnesota have been sickened with botulism after being fed recalled formula.

Overall, the agency’s letters say the infant formula remained available for purchase in stores well after the recall was announced in early November. Grocers Kroger and Albertsons were also issued warning letters.

ByHeart initially recalled certain lots of its formula last month, then expanded the recall a few days later to include all infant formula products, including cans and single-serve packs.

According to the letter posted on the FDA’s website, Target was notified Nov. 8 of the initial recall and Nov. 11 of the expanded recall covering all products.

Target told the agency it had placed an electronic block on the recalled items, but a can of the formula was later sold at a New Hampshire store.

The health regulator said officials also found the Target store in Arkansas offering a $2 discount on the recalled formula from Nov. 16 to Nov. 22.

Inspectors reported that store employees offered varying explanations for the continued availability of the formula, including confusion over which lots were affected and failure to remove newly delivered inventory.

Target said Tuesday it had notified customers who purchased ByHeart products and initiated refunds. It also reiterated that it had enacted a systematic lock to prevent future purchases and removed applicable items from its shelves and website.

The FDA said Target stores in 20 states and Walmart locations in 21 states were found to have left the formula on shelves since the recall was announced and later expanded.

A social media user noticed the formula cans were still available Nov. 15 at a Walmart store in Massachusetts and notified an employee, who removed the product from shelves.

Despite follow-up requests, the FDA said on Dec. 12 it has not received documentation that either retailer has fully implemented an effective recall.

The four chains have 15 working days upon receipt of the letters to explain what steps they have taken to prevent similar violations. The FDA warned that failure to address the problem could result in legal action, including product seizures.

“The health and safety of our customers and members is always a top priority,” a Walmart spokeswoman said Tuesday. “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.”

Fifty-one infants in 19 states have been sickened by the bacterial infection as of last week, according to the Centers for Disease Control and Prevention. A surge in cases beginning in August prompted public health investigations, including three cases identified in Minnesota. The affected babies ranged in age from about 2 weeks to nearly 9 months old.

Botulism is a rare disease caused by a toxin released from bacteria that attacks the body’s nerves and can cause breathing problems or paralysis. Symptoms can take several weeks to present after ingestion.

A Plymouth mother and father are suing the formula maker, alleging ByHeart is responsible for a case of botulism that hospitalized their 3-month-old daughter.

The Flowers family said they checked the lot numbers on their cans and didn’t see them listed in the initial recall, so they continued feeding the formula to their daughter.

The family later received a call from their local retailer and an email from the manufacturer notifying them of the recall.

In late November, ByHeart disclosed that a contract lab had found the bacteria that caused botulism in unopened cans.

It follows a separate formula recall in 2022, when the company blamed a third-party lab. Public health investigators said that was implausible and pointed to manufacturing problems at a plant in Pennsylvania, the Flowers’ suit stated.

about the writer

about the writer

Carson Hartzog

Retail reporter

Carson Hartzog is a business reporter covering Target, Best Buy and the various malls.

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Cheyanne Mumphrey/The Associated Press

Four major retailers failed to pull ByHeart infant formula from its store shelves following a recall, according to the agency’s letters. The formula has been linked to an outbreak of botulism.

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