What Happened?
In November 2025, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announced a multistate outbreak of Infant botulism linked to powdered infant formula.
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A total of 13 infants across 10 U.S. states (Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington) were hospitalised after consuming specified lots of formula.
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There have been no deaths reported to date in connection with this outbreak.
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The affected product: ByHeart Whole Nutrition Infant Formula, two specific lots: 206VABP/251261P2 and 206VABP/251131P2 (“Use by: 01 Dec 2026”).
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The formula is estimated to account for less than 1 % of the U.S. infant formula market, meaning the outbreak does not currently threaten overall supply.
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The cause of contamination is still under investigation — no direct test has yet confirmed the formula as the definitive source of toxin.
2. What Is Infant Botulism?
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It typically affects infants between ~1 month and ~6 months old, though age ranges may vary.
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Initial symptoms often include constipation, poor feeding or sucking, loss of head/neck control, difficulty swallowing, weak cry.
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It can progress to decreased facial expression, generalized muscle weakness, and difficulty breathing. Without treatment, it may lead to prolonged hospitalisation or worse.
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This outbreak involves type A infections (according to the IBTPP).
3. The Recall: What Parents Should Know
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The recall was initiated by ByHeart, at the FDA’s recommendation, on 8 November 2025.
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Only two lots are affected: 206VABP/251261P2 & 206VABP/251131P2 (Use by 01 Dec 2026). UPC: 5004496800.
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Consumers who have these products are advised to stop using them immediately, record the lot number if possible, dispose of or return the product, and clean surfaces/utensils that may have touched the formula.
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If an infant fed the recalled formula shows worrying symptoms, parents/caregivers should seek medical care without delay.
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The manufacturer emphasises that no product testing has yet confirmed contamination and that there is no historical precedent of powdered infant formula causing infant botulism.
4. Why This Matters – Risk & Context
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Although infant botulism is rare, its severity in infants makes any outbreak especially concerning.
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The fact that all 13 reported infants consumed the same formula brand and lots suggests a strong epidemiologic signal — though causality hasn’t yet been confirmed.
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Because the brand holds <1 % market share, the clustering of cases raises alarms about possible manufacturing or contamination issues in the affected lot(s).
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For parents, this event underscores the importance of monitoring lot codes, staying aware of recalls, and being vigilant for symptoms in infants, especially if using powdered formulas.
5. What Parents & Caregivers Should Do
If you have the formula in question:
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Check the bottom of each canister for lot code and use-by date. If it matches the recalled lots (206VABP/251261P2 or 206VABP/251131P2, Use by 01 Dec 2026), discontinue use immediately.
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Dispose of the formula or return to point-of-purchase. Clean feeding equipment, surfaces, and utensils with hot, soapy water or run through dishwasher.
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Contact the manufacturer (ByHeart) for any replacement or refund options (as this recall is voluntary).
If your infant shows symptoms:
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Watch for signs: poor feeding, weak cry, droopy eyelids, low muscle tone, difficulty swallowing or breathing.
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Seek prompt medical evaluation. Do not wait for lab tests if the clinical suspicion is strong.
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Inform your pediatrician about any formula brands and lots used.
For future formula use & safety awareness:
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Even though this recall is isolated, always check formulas for recalls and lot warnings.
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Maintain good feeding hygiene: proper preparation of powdered formula (according to manufacturer instructions) may help reduce general risks of contamination.
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Breastfeeding remains the gold standard for infant nutrition when possible; formula is safe but attention to quality and supply matters.
6. What We Don’t Yet Know / Ongoing Investigation
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The precise source and mechanism of contamination are not yet identified. The FDA investigators are working to determine whether other products/batches are impacted.
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Laboratory results on leftover formula are still pending in several states.
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While all 13 infants reported consumption of the recalled lots, the agency has not yet confirmed direct causation (i.e., formula → botulism toxin) historically for formula products.
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U.S. Food & Drug Administration (FDA) — Outbreak investigation of infant botulism: infant formula (November 2025)
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025 U.S. Food and Drug Administration+1 -
U.S. Centers for Disease Control and Prevention (CDC) — Infant Botulism Outbreak Linked to Infant Formula (November 2025)
https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html CDC -
U.S. Department of Health & Human Services / FDA — “In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula”
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/response-broader-fda-investigation-byheart-initiates-voluntary-recall-two-batches-infant-formula U.S. Food and Drug Administration -
ByHeart Inc. — Company announcement: voluntary recall of two batches of infant formula
https://byheart.com/pages/in-response-to-a-broader-fda-investigation-byheart-initiates-a-voluntary-recall-of-two-batches-of-infant-formula ByHeart -
AP News via The Washington Post — “Infant botulism in 10 US states linked to formula being recalled”
https://apnews.com/article/91019e385a98a2fceb26a12005ea3fbb AP News+1 -
People magazine — “Baby Formula Sold Nationwide Recalled for Possible Link to ‘Potentially Fatal Illness’”
https://people.com/infant-formula-recalled-botulism-outbreak-11846383 people.com
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