NEW YORK, NY (November 11, 2025) — The U.S. Food and Drug Administration (FDA) has announced that ByHeart Inc., a next-generation baby nutrition company, has expanded its voluntary recall to include all batches of its Whole Nutrition Infant Formula and Anywhere Pack™ products nationwide. The expansion follows an ongoing FDA and CDC investigation into an increase in reported cases of infant botulism.
ByHeart recall: quick summary
ByHeart’s latest recall marks an expansion of its earlier November 8, 2025, action, when two batches of formula were voluntarily removed from the market.
The FDA confirmed that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, but the company is proceeding “out of an abundance of caution.”
ByHeart is working closely with both the FDA and the California Department of Public Health (CDPH) as part of the ongoing investigation.
The recall covers 24-ounce cans and 0.6-ounce Anywhere Pack™ formula products sold nationwide.
Consumers are advised to discontinue use and dispose of all affected products immediately.
Official recall details
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Recall date: November 11, 2025
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Announced by: U.S. Food and Drug Administration (FDA)
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Company name: ByHeart Inc.
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Product name: Whole Nutrition Infant Formula (24 oz cans and 0.6 oz Anywhere Pack™)
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Reason for recall: Potential foodborne illness — Clostridium botulinum
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Product details: Can UPC: 85004496800 || Anywhere Pack™ UPC: 85004496802 || Distributed nationwide
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What consumers should do: Immediately stop using and dispose of any affected product. Contact ByHeart for replacement or refund at [email protected] or 1-833-429-4327.
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Stick around to find out more about this recall.
What happened?
The FDA said ByHeart initiated the expanded recall after the agency and the CDC reported a total of 84 infant botulism cases in the U.S. since August 2025. The company first took precautionary action on November 8, recalling two batches of formula.
In its updated notice, the FDA confirmed that “no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.” The recall was announced in coordination with the FDA and state health officials.
The company stated that it is taking several proactive measures, including:
- Recalling all batches nationwide,
- Conducting third-party testing of every formula batch, and
- Providing full access to regulators for facility and product testing.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, Co-Founder and President of ByHeart.
Affected products
Brand | Product | Size | UPC | Best by date | Issue | Affected states |
|---|---|---|---|---|---|---|
ByHeart | Whole Nutrition Infant Formula | 24 oz can | 85004496800 | All | Clostridium botulinum risk | Nationwide |
ByHeart | Anywhere Pack™ | 0.6 oz packet | 85004496802 | All | Clostridium botulinum risk | Nationwide |
What caused the issue?
According to the FDA notice, the broader investigation seeks to determine the source of the Clostridium botulinum contamination linked to several infant illnesses.
While no unopened ByHeart products have tested positive, the agency emphasized that infant botulism is a rare but serious illness that can cause muscle weakness, respiratory difficulty, and feeding issues. So far, no confirmed illnesses have been directly linked to ByHeart formula.
Questions you might have
Stop using it immediately. Contact your healthcare provider if your child shows any symptoms such as constipation, poor feeding, a weak cry, or breathing difficulties.
Check the bottom of the can or packet for the UPC codes and lot numbers listed above. All batches are included in this expanded recall.
As of November 11, no illnesses have been confirmed to be directly associated with the ByHeart formula.
The company broadened the recall after additional testing and investigation revealed potential cross-contamination concerns during production.
Yes. This expanded recall builds on the initial voluntary recall announced earlier this month. It now includes more product lots as a precautionary measure.
Consumers should safely dispose of the product or return it to the place of purchase for a full refund. Do not donate or use it.
Only unaffected batches or products not listed in the recall are considered safe to use. Always check the lot code before feeding.
Contact your healthcare provider if your child shows any signs of illness, such as vomiting, diarrhea, dehydration, fever, or unusual lethargy.
Visit the FDA’s recall announcement for up-to-date information.
The company has halted production at the affected facility, implemented additional safety protocols, and is working closely with the FDA to ensure product safety before resuming operations.
Here’s what you should do
- Dispose of or return affected formula products.
- Check UPC codes on the bottom of cans or packets.
- Contact [email protected] or 1-833-429-4327 for refunds or replacements.
- Report adverse events to the FDA’s MedWatch program.
Behind the brand
Founded in New York, ByHeart is a U.S.-based infant nutrition company focused on developing clean-label, science-driven formulas. The company stated that it has “ceased distribution of the affected product” and is working closely with the FDA and the California Department of Public Health (CDPH) during the ongoing investigation.
In an open letter published on its website on November 11, 2025, co-founders Mia Funt and Ron Belldegrun expressed deep concern and accountability, writing:
“We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do.”
They emphasized that the nationwide voluntary recall was made “to ensure your baby’s safety” and reiterated their cooperation with federal investigators.
Source86 reached out to ByHeart for additional comment on the expanded recall, but has not yet received a response.
Other relevant recalls
This expanded recall follows ByHeart’s November 8, 2025, voluntary recall of two formula batches. Similar safety-related recalls were issued earlier this year by other manufacturers — including First and Last Bakery, KRASNIY OKTYABR INC. USA, and Walker’s Wine Juice — reflecting heightened FDA oversight of infant nutrition and food safety standards.
“Infants are especially vulnerable because their gut microbiomes are not yet developed to prevent the growth of Clostridium botulinum spores, which can germinate and produce toxin directly in their intestines.” — Darin Detwiler, Food Policy & Safety Expert at Northeastern University
Eran Mizrahi, CEO of Source86, added:
“Every recall is a reminder that food safety isn’t just about compliance; it’s about trust. Transparency and quick action are key to maintaining that trust.”
Ensuring safe eats
ByHeart’s swift nationwide recall reflects both the seriousness of the FDA’s investigation and the company’s commitment to consumer safety. While no contamination has been confirmed, the proactive approach serves as a reminder for all manufacturers to uphold rigorous safety standards.
At Source86, we help food brands manage ingredient sourcing, FSQA oversight, and private-label production with transparency and precision, ensuring that when recalls occur, supply chains are prepared to respond quickly. Contact Us!
