{"id":2645,"date":"2025-11-17T21:09:18","date_gmt":"2025-11-17T21:09:18","guid":{"rendered":"https:\/\/www.vdh.virginia.gov\/clinicians\/?page_id=2645"},"modified":"2026-01-21T00:25:06","modified_gmt":"2026-01-21T00:25:06","slug":"infant-botulism-outbreak-linked-to-recalled-infant-formula","status":"publish","type":"page","link":"https:\/\/www.vdh.virginia.gov\/clinicians\/clinician-letters\/infant-botulism-outbreak-linked-to-recalled-infant-formula\/","title":{"rendered":"Infant Botulism Outbreak Linked to Recalled Infant Formula\u00a0"},"content":{"rendered":"
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Infant Botulism Outbreak Linked to Recalled Infant Formula\u00a0<\/strong><\/p>\n

November 18, 2025<\/span>\u00a0<\/span><\/p>\n

Dear Colleague:\u202f<\/span>\u00a0<\/span><\/p>\n

This letter provides information on an <\/span>outbreak of infant botulism<\/span><\/a> linked to ByHeart powdered infant formula. At this time, there are no cases of infant botulism from Virginia included in this outbreak.<\/span>\u00a0<\/span><\/p>\n

Background<\/span><\/b>\u202f<\/span>\u00a0<\/span><\/p>\n

The Centers for Disease Control and Prevention (CDC) and public health officials in several states, the <\/span>Infant Botulism Treatment and Prevention Program<\/span><\/a>, and the FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula.\u202fEpidemiologic data show that ByHeart Whole Nutrition infant formula might be contaminated with <\/span>Clostridium botulinum<\/span><\/i> and is making infants sick.\u202f \u202f<\/span>\u00a0<\/span><\/p>\n

As of November 14, 23 infants with suspected or confirmed infant botulism have been reported from 13 states: Arizona, California (2), Illinois (2), Kentucky, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. All 23 infants were hospitalized and treated with BabyBIG\u00ae (Botulism Immune Globulin Intravenous medication). No deaths have been reported<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>\n

CDC and FDA recommend that parents and caregivers immediately stop use of all ByHeart Whole Nutrition infant formula, including cans and single serve packets.<\/span><\/b> Preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula. On November 11, ByHeart Inc. <\/span>recalled<\/span><\/a> all ByHeart Whole Nutrition infant formula products. FDA does not anticipate any formula shortages as a result of this outbreak.\u202f<\/span>\u00a0<\/span><\/p>\n

Infant botulism occurs when an infant ingests spores from a type of bacteria called <\/span>Clostridium botulinum<\/span><\/i>, which then grows in the large intestine and produces toxin that blocks the neuromuscular junction by inhibiting the release of acetylcholine. Initial signs and symptoms often include constipation, difficulty feeding (difficulty sucking or swallowing), loss of head control, weak facial expression, and reduced muscle tone. Without prompt recognition and treatment, descending paralysis may progress and involve the respiratory muscles, potentially leading to life-threatening respiratory failure. The time from ingestion to symptom presentation can be up to 30 days.\u202f<\/span>\u00a0<\/span><\/p>\n

Recommendations for Clinicians<\/span><\/b>\u202f<\/span>\u00a0<\/span><\/p>\n

Consider infant botulism as a clinical diagnosis in any infant presenting with unexplained weakness, poor feeding, decreased head control, or difficulty swallowing \u2014 especially if the infant has consumed ByHeart formula.\u202f<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>When a case is suspected:<\/span><\/b>\u202f<\/span>\u00a0<\/span><\/p>\n