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FDA Probes Infant Botulism Outbreak Linked to Recalled Baby Formula

by Andrew Powell
November 9, 2025 at 5:24 pm
in News
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FDA Probes Infant Botulism Outbreak Linked to Recalled Baby Formula

A Caucasian parent scoops infant formula for feeding their baby into a bottle. Current formula shortage in the United States has many families feeling food insecurity. Image via RyanJLane/Getty Images

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Federal and state health officials are investigating 13 cases of infant botulism in 10 states linked to recalled baby formula, authorities said Saturday.

According to The Associated Press, ByHeart Inc. agreed to recall two lots of its Whole Nutrition Infant Formula, the Food and Drug Administration announced.

All 13 infants were hospitalized after consuming formulas from lots 206VABP/251261P2 and 206VABP/251131P2. The cases were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

No deaths have been reported. The FDA said it is investigating how the contamination occurred and whether other products were affected.

Should the FDA take further action on the infant formula recall related to botulism cases?

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The Centers for Disease Control and Prevention said the recalled product made up about 1% of national formula sales.

Consumers who purchased the recalled formula should note the lot number before disposing of or returning it, the CDC advised. Items and surfaces that came into contact with the product should be washed in a dishwasher or with hot, soapy water.

Parents should seek medical care if an infant who consumed the formula shows signs such as poor feeding, loss of head control, difficulty swallowing, or reduced facial expression.

Infant botulism is caused by bacteria that produce toxins in the large intestine, and symptoms can take weeks to appear, the CDC warned.

Tags: 13 casesBotulismByHeart Inc.recallU.S. News
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Andrew Powell

Andrew Powell

IJR, Contributor Writer

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