Latest Update: The FDA has issued urgent warning letters
to Walmart, Target, Kroger, and Albertsons after inspectors found recalled
ByHeart infant formula still being sold in stores across multiple states,
despite a nationwide recall linked to an outbreak of infant botulism.
Recalled Infant Formula Prompts FDA Warning to Walmart,
Target, and Other Retailers
The U.S. Food and Drug Administration (FDA) has sent
warning letters to four of the nation’s largest retailers—Walmart, Target,
Kroger, and Albertsons—for failing to promptly remove recalled ByHeart
Whole Nutrition Infant Formula from store shelves. The recall, initiated on
November 8, 2025, was expanded on November 11 to include all
ByHeart formula products after being linked to a botulism outbreak that
has hospitalized 51 infants across 19 states.
Despite repeated notifications, FDA inspectors discovered
the recalled formula remained available for purchase for weeks after the
recall:
- Walmart:
Products found in 21 states between Nov. 12–26.
- Target:
Formula remained on shelves in 20 states until Nov. 20, with some
stores even promoting discounts on the recalled packs.
- Albertsons:
Recalled formula found in 11 states between Nov. 12–19.
- Kroger:
Products discovered in 10 states during the same period.
The FDA emphasized that these failures highlight serious
gaps in recall effectiveness at the retail level, especially for products
consumed by vulnerable populations like infants. Inspectors conducted over
4,000 checks nationwide, finding recalled formula in 175 locations
across 36 states.
Health Risks
The contaminated formula was linked to Clostridium
botulinum, the bacteria that causes infant botulism. Symptoms
include:
- Constipation
- Difficulty
feeding (sucking/swallowing)
- Weak
cry and loss of head control
- In
severe cases, breathing difficulties
All affected infants have been hospitalized and treated with
antitoxin medication. No deaths have been reported.
Retailer Response
- Walmart
stated that sales restrictions were implemented and products removed, but
FDA inspectors still found formula in stores.
- Albertsons
claimed it worked closely with regulators to remove products.
- Target
and Kroger have yet to provide detailed responses.
The FDA has given all four companies 15 working days
to explain corrective actions or face potential enforcement measures, including
product seizures.
This incident underscores the critical responsibility of
retailers in ensuring recalled products are swiftly removed from shelves.
The FDA warns that failure to act promptly can endanger public health,
particularly infants who rely on formula as their sole source of nutrition.
