Updated: November 9, 2025
Federal and state health officials are investigating a multistate outbreak of infant botulism that has hospitalized 13 babies across 10 U.S. states and prompted ByHeart to recall two lots of its Whole Nutrition Infant Formula. No deaths have been reported. The investigation remains active and laboratory testing is ongoing, officials said. 1
Key takeaways
- Recall: ByHeart voluntarily recalled two lots of Whole Nutrition Infant Formula on Nov. 8, 2025. See exact lot codes below. 1
- Impact:13 infants in 10 states were hospitalized; no deaths reported. Illness onsets range from mid‑August to November 2025. 2
- States affected: AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA. 3
- Testing status: Federal testing continues; California’s state lab says preliminary results “suggest the presence” of the botulism‑causing bacterium in one can fed to a sick infant. 4
- Supply: ByHeart accounts for <1% of U.S. formula sales; officials do not expect a shortage impact. 1
What’s being recalled (check your can)
ByHeart Whole Nutrition Infant Formula — only the two lots below:
- Lot 206VABP/251261P2 — “Use by 01 Dec 2026”
- Lot 206VABP/251131P2 — “Use by 01 Dec 2026”
The lot code and “Use by” date are printed on the bottom of the can. The product is sold online and at major retailers nationwide. 3
UPC (from company announcement): 5004496800. 5
Where cases have been reported
As of Nov. 8, 2025, health officials report 13 suspected or confirmed infant botulism cases across 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. All 13 infants were hospitalized; none have died. Ages range from 16 to 157 days. Illnesses began mid‑August through November. All infants’ caregivers reported feeding ByHeart’s Whole Nutrition Infant Formula. Many received BabyBIG®, the botulism antitoxin provided by California’s Infant Botulism Treatment and Prevention Program. 2
What parents and caregivers should do now
- Stop using the recalled lots immediately. Throw them away or return them to the place of purchase. Record the lot number first if possible. 1
- Clean any scoops, bottles, caps, counters, or surfaces that may have touched the formula (hot, soapy water or dishwasher). 1
- Watch for symptoms of infant botulism and seek medical care right away if they appear (see list below). Symptoms can take several weeks to develop. 1
- Questions about treatment? Clinicians can consult the Infant Botulism Treatment and Prevention Program 24/7 at 510‑231‑7600. 1
- Report problems or adverse events to FDA’s MedWatch/Consumer Complaint Coordinators; ByHeart says it will replace discarded cans at no cost for affected batches. 5
Symptoms to watch for (infant botulism)
Early signs often include constipation, poor feeding (trouble sucking or swallowing), loss of head control, weak or altered cry, decreased facial expression, and can progress to breathing difficulties without prompt care. 1
Why this recall happened
On Nov. 8, FDA recommended a voluntary recall “due to the number of cases, severity of illness, and the strong epidemiological signal” linking reported illnesses to ByHeart’s powdered formula; ByHeart agreed and initiated the recall of the two lots above. Officials are working to determine how and where contamination may have occurred and whether any additional products could be affected. Testing of leftover formula from homes is underway. 3
Important nuance: California’s public health lab reports that preliminary testing of one can fed to a sick infant “suggests the presence” of the bacterium that produces botulinum toxin; confirmatory testing can take several days. At the same time, ByHeart says no product has tested positive in its or regulators’ testing to date and emphasizes the recall is out of “an abundance of caution.” 4
Where the formula was sold
ByHeart’s Whole Nutrition Infant Formula is sold online and at major retailers nationwide. California health officials list availability via the company’s website and retailers including Amazon, Kroger, Walmart, Whole Foods, Target, and SamsClub.com, among others. 3
Will this affect formula supply?
Officials say the recalled brand accounts for less than 1% of U.S. formula sales, and no national shortage is expected as a result of this recall. 1
Quick timeline
- Mid‑August 2025: First illness onsets reported in the outbreak window. 2
- Nov. 8, 2025: FDA and CDC publish outbreak notices; ByHeart voluntarily recalls two lots. 3
- Nov. 8–9, 2025: California health officials say preliminary testing suggests presence of the botulism‑causing bacterium in one can; federal testing continues. 4
- Nov. 9, 2025: Newsrooms report 13 hospitalized infants across 10 states, no deaths. Ages range roughly 2 weeks to 5 months. 6
FAQ
Is it safe to use ByHeart cans from other lots?
Authorities have only recalled the two lot codes listed above. Follow official guidance: do not use recalled lots, monitor infants for symptoms, and consult your pediatrician with any concerns. FDA’s investigation is ongoing. 3
How do I check my can?
Turn the can over and locate the lot code and Use‑By date on the bottom. If your lot matches either 206VABP/251261P2 or 206VABP/251131P2 (Use‑By 01 Dec 2026), discard/return it and clean any items it touched. 3
What if I already fed my baby the recalled formula?
Watch for symptoms (above) for several weeks and seek medical care immediately if any appear. Bring the formula container (or record the lot code) to your clinician if available. 1
Who to contact
- Clinicians: Infant Botulism Treatment and Prevention Program 510‑231‑7600 (24/7). 1
- Consumers: ByHeart customer support (24/7) and FDA complaint channels; the company says it will replace cans from the recalled batches. 5
Sources & further reading
- CDC outbreak advisory & guidance (case counts, what to do, recall details). 1
- CDC investigation update (states, age range, BabyBIG®, illness onset window). 2
- FDA outbreak page (lot codes, states, investigation status). 3
- ByHeart company announcement via FDA (voluntary recall, replacement policy, UPC). 5
- California Department of Public Health (preliminary state lab results; retailer distribution). 4
- Washington Post same‑day report (ages, hospitalization, agency statements). 6
Editor’s note: This article reflects information available as of November 9, 2025. Health agencies will update advisories as lab results and trace‑back findings become available. For the most current instructions, follow CDC and FDA guidance. 1
