Infant formula sold in California recalled amid botulism cases; 31 hospitalized

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Updated: 5:55 PM PST Nov 20, 2025

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All batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack have been voluntarily recalled nationwide due to potential Clostridium botulinum contamination. As of Nov. 19, 2025, 31 infants have been hospitalized, and no deaths have been reported, according to the FDA.The bacterium can cause life-threatening illness or death. The recall includes all batch codes and use-by dates for the following products:ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Pack™, 14 packets per package, UPC: 5004496802Additional testing is underway, and results are expected in the coming weeks.ByHeart is urging customers who purchased its Whole Nutrition Infant Formula (cans) and Anywhere Pack to stop using the products immediately and follow FDA guidance.What to do now:Photograph or write down the information on the bottom of the package.Store the container safely and clearly label it DO NOT USE.If your child develops symptoms, your state health department may request the container for testing. If no symptoms appear after 30 days, discard the container.If your infant shows symptoms consistent with infant botulism, contact your health care provider immediately.How to report a problem:Submit a Product Problem through the FDA’s SmartHub.File a Voluntary MedWatch report (online or by mail).Questions and support:Email ByHeart at hello@byheart.com or call 1-833-429-4327 (available 24/7).You can also visit the company’s website for more information.

SALINAS, Calif. —

All batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack have been voluntarily recalled nationwide due to potential Clostridium botulinum contamination.

As of Nov. 19, 2025, 31 infants have been hospitalized, and no deaths have been reported, according to the FDA.

The bacterium can cause life-threatening illness or death.

The recall includes all batch codes and use-by dates for the following products:

ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Packâ„¢, 14 packets per package, UPC: 5004496802

Additional testing is underway, and results are expected in the coming weeks.

ByHeart is urging customers who purchased its Whole Nutrition Infant Formula (cans) and Anywhere Pack to stop using the products immediately and follow FDA guidance.

What to do now:

Photograph or write down the information on the bottom of the package.Store the container safely and clearly label it DO NOT USE.If your child develops symptoms, your state health department may request the container for testing. If no symptoms appear after 30 days, discard the container.

If your infant shows symptoms consistent with infant botulism, contact your health care provider immediately.

How to report a problem:

Submit a Product Problem through the FDA’s SmartHub.File a Voluntary MedWatch report (online or by mail).

Questions and support:

Email ByHeart at hello@byheart.com or call 1-833-429-4327 (available 24/7).You can also visit the company’s website for more information.