Infant Botulism Outbreak Prompts Recall of Specific ByHeart Formula Lots

The U.S. Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state health officials, is investigating a multistate outbreak of infant botulism linked to specific lots of ByHeart Whole Nutrition Infant Formula. The ongoing investigation has identified 13 infants across 10 states who have fallen ill, with all cases reporting consumption of the ByHeart brand powdered infant formula.

The affected product includes two specific lots of ByHeart Whole Nutrition Infant Formula: Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both with a “Use by” date of December 1, 2026. Consumers can find this lot code and expiration date on the bottom of the infant formula can. While the company voluntarily agreed to recall these lots following recommendations from the FDA, the investigation is continuing to determine the source of contamination and if any other products may be affected. ByHeart Whole Nutrition Infant Formula represents a small fraction of the infant formula market, and this recall is not anticipated to cause widespread shortages for parents and caregivers.

Infant botulism, a serious illness, can manifest with symptoms such as constipation, poor feeding, loss of head control, and difficulty swallowing. In severe cases, these symptoms can progress to breathing difficulties and respiratory arrest. Symptoms typically appear several weeks after ingesting contaminated formula and are diagnosed clinically. As of the latest update on November 8, 2025, there have been 13 reported illnesses and 13 hospitalizations, with no fatalities associated with this outbreak. The affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

Parents and caregivers are strongly advised to immediately cease using and discard the specified lots of ByHeart Whole Nutrition Infant Formula. If a child has consumed the affected formula and is exhibiting any signs of botulism, such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, immediate medical attention should be sought. Parents are also encouraged to record the lot information from the packaging before discarding the product.

For healthcare professionals who suspect a patient may have infant botulism, immediate consultation is available 24/7 by calling 510-231-7600. The ByHeart Whole Nutrition Infant Formula has been available for purchase online and at major retail outlets nationwide. The FDA is working with ByHeart, Inc. to ensure that all potentially impacted product is removed from the market. Further updates on the investigation will be provided as more information becomes available.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration.

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