The U.S. Food and Drug Administration is warning consumers again about a scary infant formula recall after it found the product still for sale on store shelves in a whopping 36 states.
The original recall was announced a month ago because the formula was linked to an outbreak of botulism that sickened children in 10 states, but in some cases, retailers have not gotten the message. Here’s more information about the recall, plus the new warning from the FDA.
Which Formula Was Recalled?
In early November, the FDA issued a voluntary recall for ByHeart Whole Nutrition Infant Formula. It has been updated to include all cans and Anywhere Packs of ByHeart infant formula, with any batch codes and use by dates. They were distributed nationwide in stores and online by multiple retailers. The two products are:
- ByHeart Whole Nutrition Infant Formula, 24-ounce can, UPC: 5004496800
- ByHeart Whole Nutrition Infant Formula, 0.60-ounce Anywhere Pack, 14 packets per package, UPC: 5004496802
The recalled ByHeart infant formula has been linked to an outbreak of infant botulism that has sickened 51 children in 19 states. Infant botulism occurs in babies when they ingest certain bacteria called clostridium botulinum. It causes symptoms including constipation, weak feeding, eyelid drooping, and respiratory difficulty, and can lead to death.
What Is the New FDA Warning?
After the recall was issued, along with a subsequent recall update, the FDA issued warning letters on December 12 to a number of retailers that failed to remove the recalled product from shelves.
The letters came after weeks-long investigations and monitoring of retailers. “FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers,” said the FDA in a news release. “Through this effort, we found that recalled infant formula continued to be found on store shelves — for over three weeks in one case, in over 175 locations across 36 states.”
The warning letters were sent to four major retailers: Target, Walmart, Albertsons, and Kroger. Each one detailed exactly where and when the recalled ByHeart formula was seen on store shelves after the recall was announced.
In the warning letter to Target, investigators even saw the formula advertised on sale after the recall had been announced. “The inadequacy of Target’s recall response was further demonstrated on November 20, 2025, when Arkansas state partners observed ByHeart Whole Nutrition Infant Formula single-serve ‘anywhere pack’ sticks on a Target store shelf with promotional “Sale!” signage offering a $2.00 discount on the recalled formula from November 16 to November 22, 2025.”
What Should I Do if I Have the Recalled Formula?
If you have the recalled ByHeart infant formula, you should immediately stop using it, the FDA advises. Because of the serious nature of the illness, you are advised not to throw the product out. Instead, the FDA advises you to take these steps:
- Take a photo or record the information on the bottom of the package.
- Keep the container in a safe spot and be sure to label that product as DO NOT USE.
- If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
If your child is exhibiting any symptoms, you should contact a healthcare provider immediately. If you have any questions related to the product recall, you can visit ByHeart’s website for more information and contact information.
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