Urgent: FDA Issues National Baby Formula Recall Over Botulism Risk

ByHeart products have triggered a nationwide baby formula recall after 51 infants were hospitalized with infant botulism . Parents and caregivers should know that ByHeart Inc. has recalled their entire line of Whole Nutrition infant formula products on November 11, 2025. The recall includes all canned and single-serve packet formats .

The recall affects roughly 1% of all infant formula sold in the United States . This outbreak won't cause shortage issues, but its severity demands immediate attention. Parents must stop using any ByHeart formula right away .

Clostridium botulinum bacteria causes infant botulism, a rare but dangerous illness . Botulism symptoms can surface within days or take several weeks to appear after exposure . Parents should look for specific warning signs. Constipation usually appears as the original symptom, followed by poor feeding, trouble swallowing, weak facial expressions, and the baby's inability to control head movement . The symptoms can develop anywhere between 18 hours to 30 days after consuming the formula .

FDA recalls ByHeart formula over botulism contamination

The FDA's investigation led to ByHeart's voluntary recall of two specific formula batches on November 8, 2025. This action came after reports of infant botulism cases across the country [1]. The affected batches were:

• Batch Code: 251261P2, Use by: 01 Dec 2026

• Batch Code: 251131P2, Use by: 01 Dec 2026

• UPC: 85004496800 [2]

ByHeart received reports of 83 infant botulism cases since August 2025, and 13 of these infants had taken their formula [3]. The company expanded its recall on November 11 to cover all ByHeart Whole Nutrition Infant Formula products, including canned and single-serve "Anywhere Pack" formats [4].

The situation became more serious after tests found Clostridium botulinum in some formula samples [5]. Health officials could not eliminate the possibility that "contamination might have affected all ByHeart formula products" made since March 2022 when the company started selling formula [4].

The recalled products represent about 1% of all infant formula sold in the United States [6]. The effects have been devastating, with sick infants in 19 states. Arizona, California, Illinois, Kentucky, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington reported cases [7].

ByHeart sold these products through their website, major retailers, and online marketplaces [6].

CDC and FDA investigate source of infant botulism outbreak

Health officials from the CDC, FDA, and California Department of Public Health found the first multi-state infant botulism outbreak linked to commercial formula [6]. Reports show 51 infants with confirmed or suspected infant botulism who took ByHeart formula across 19 states [6]. These babies needed hospital care, but fortunately, none of them died [8].

Staff at California Department of Public Health's Infant Botulism Treatment and Prevention Program noticed something unusual. They saw a sudden rise in cases and quickly alerted federal officials [9]. Lab tests later confirmed Clostridium botulinum type A in an opened formula can from a sick infant's home [10]. ByHeart's independent lab (IEH) also found C. botulinum in several formula samples [5].

The contamination problem turned out to be more serious than anyone expected. Tests on 36 samples from three different lots showed five positive results for the bacteria [11]. This led investigators to warn that "we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated" [11].

The CDC and state health departments are talking to caregivers about what the infants ate before getting sick [10]. Officials continue their work to find exactly where the contamination started [6].

Retailers face scrutiny for selling recalled formula

Federal regulators found that there was a serious breakdown in the recall process. Four major retailers - Target, Walmart, Kroger, and Albertsons - kept selling potentially dangerous ByHeart formula weeks after the recall notice. The FDA sent warning letters to these retailers on December 12 about this serious safety violation [12].

FDA investigators checked more than 4,000 retail locations nationwide and found recalled formula still sitting on shelves at over 175 stores in 36 states. Some stores had these products three weeks after the recall started [2]. Target's situation raised major concerns, as inspectors found the recalled formula in 20 states through November 20 [4]. A Target store in Arkansas made things worse by putting up a "Sale!" sign that offered a $2.00 discount on the dangerous product from November 16-22 [13].

The problem spread beyond Target. Walmart had recalled products in 21 states, Kroger in 10 states, and Albertsons in 11 states [4]. Store workers gave different reasons when asked - some didn't know about the recall, while others were confused about which products needed removal [13].

These retailers must respond with their plan to fix these issues within 15 working days [12]. Walmart said they were quick to react by stopping sales, and Albertsons confirmed they have removed all ByHeart products from their stores [4].

Conclusion

The ByHeart baby formula recall stands as one of the most important infant safety alerts of 2025. Parents should check their formula supplies right away and stop using any ByHeart products, whatever the batch numbers or when they bought them. This unprecedented case is the first multi-state infant botulism outbreak from commercial formula that has affected babies nationwide.

Parents should stay alert for botulism symptoms. These include constipation, poor feeding, trouble swallowing, weak facial expressions, and loss of head control. The recalled products make up just 1% of the U.S. formula market, but the risk of severe illness means you need to act fast.

The most worrying part is that major retailers failed to protect their customers properly. Recalled formula was still found on store shelves weeks after the notice went out. This shows a troubling breakdown in our food safety systems. Without doubt, manufacturers and retailers need more oversight and must be held accountable.

No deaths have happened yet, but 51 babies have needed hospital care. This shows how serious this public health emergency really is. Federal and state agencies are still investigating how the contamination occurred. Any family affected by this recall should see their doctor immediately if their baby shows suspicious symptoms.

This ByHeart formula recall reminds us that staying alert protects our most vulnerable citizens. We just need better safety protocols throughout the food production and distribution chain, especially for baby products.

Key Takeaways

This urgent FDA recall affects all ByHeart baby formula products due to botulism contamination that has hospitalized 51 infants across 19 states. Here are the critical points every parent and caregiver must know:

• Stop using all ByHeart formula immediately - The recall includes all products regardless of batch numbers or expiration dates since contamination may affect all lots produced since March 2022.

• Watch for botulism symptoms in infants - Key warning signs include constipation (most common first symptom), poor feeding, difficulty swallowing, weak facial expressions, and loss of head control.

• Check store shelves carefully - Major retailers including Target, Walmart, Kroger, and Albertsons failed to remove recalled products promptly, with contaminated formula found on shelves weeks after the recall announcement.

• Seek immediate medical attention - All 51 affected infants required hospitalization, and symptoms can appear anywhere from 18 hours to 30 days after exposure to contaminated formula.

• This is the first multi-state infant botulism outbreak linked to commercial formula in U.S. history, marking an unprecedented public health emergency that demands swift parental action and improved safety protocols.

The recall affects approximately 1% of the U.S. infant formula market, so supply shortages are not expected. However, the severity of infant botulism and the widespread distribution of these products make immediate action essential for infant safety.

FAQs

Q1. What products are included in the ByHeart baby formula recall?

The recall includes all ByHeart Whole Nutrition infant formula products, in both canned and single-serve packet formats, regardless of batch number or expiration date.

Q2. What are the symptoms of infant botulism that parents should watch for?

Key symptoms include constipation (often the first sign), poor feeding, difficulty swallowing, weak facial expressions, and loss of head control. Symptoms can appear from 18 hours to 30 days after exposure.

Q3. How widespread is the botulism outbreak linked to ByHeart formula?

The outbreak has affected 51 infants across 19 states, all of whom required hospitalization. This is the first multi-state infant botulism outbreak linked to commercial formula in U.S. history.

Q4. What should parents do if they have ByHeart formula at home?

Parents should immediately stop using any ByHeart formula products they have and consult their healthcare provider if their child shows any suspicious symptoms.

Q5. Were there issues with the recall's implementation at retail stores?

Yes, major retailers, including Target, Walmart, Kroger, and Albertsons, failed to promptly remove recalled products. FDA investigators found recalled formula still on shelves at over 175 locations across 36 states, weeks after the recall was announced.

References

[1] - https://byheart.com/pages/in-response-to-a-broader-fda-investigation-byheart-initiates-a-voluntary-recall-of-two-batches-of-infant-formula?srsltid=AfmBOoqmIvZTcJkHWtr0fKVHBQrHdbr9KO-gjZLY7IIe2wb-6raRd65V
[2] - https://www.food-safety.com/articles/10983-fda-urges-industry-to-improve-recall-efficiency-after-delay-in-removing-byheart-formula-from-stores
[3] - https://byheart.com/pages/in-response-to-a-broader-fda-investigation-byheart-initiates-a-voluntary-recall-of-two-batches-of-infant-formula?srsltid=AfmBOoo_tqvWLP2rYkRFeOPjp1l0Oqm5zhUHE5aF9TEqZRINpBCx5iby
[4] - https://www.cbsnews.com/news/fda-byheart-walmart-target-kroger-and-albertsons/
[5] - https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-updates-information-regarding-voluntary-recall-all-batches-byheart-whole-nutrition-infant
[6] - https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
[7] - https://www.consumerreports.org/babies-kids/baby-product-recalls/byheart-infant-formula-recalled-for-botulism-risk-a1915065509/
[8] - https://www.food-safety.com/articles/11009-senator-demands-answers-from-byheart-about-infant-formula-botulism-outbreak
[9] - http://publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5182
[10] - https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html
[11] - https://www.pbs.org/newshour/health/all-lots-of-byheart-baby-formula-may-be-contaminated-with-botulism-bacteria-tests-show
[12] - https://www.fda.gov/news-events/press-announcements/fda-takes-action-improve-recall-effectiveness-following-infant-botulism-outbreak-investigation
[13] - https://www.healthbeat.org/2025/12/19/byheart-baby-formula-botulism-outbreak-recall-fda/