FDA Calls for Stronger Infant Formula Safeguards After Botulism Outbreaks

The US Food and Drug Administration has urged infant formula manufacturers and their suppliers to strengthen ingredient oversight after separate multistate botulism outbreaks associated with Nara Organics and ByHeart powdered infant formulas.

The US Food and Drug Administration has called for greater vigilance across the infant formula supply chain after recent investigations raised concerns about how contaminated ingredients or other microbiological risks may enter finished products.

In an industry communication issued on 13 July 2026, the FDA said manufacturers should have a clear understanding of where their ingredients come from, how they are produced, what hazards they may carry and whether suppliers are controlling those hazards effectively. The agency referred specifically to multistate infant botulism outbreaks associated with ByHeart and Nara Organics powdered infant formulas. Both investigations led to recalls, and the FDA continues to examine shared ingredient suppliers. [A]

The FDA also told manufacturers to respond promptly to recall notices, outbreak investigations and import alerts. It warned that overlooking or underestimating these signals may increase preventable risks to infants.

The new action goes beyond one recalled product

The latest FDA communication is not a new Nara recall. Nara Organics recalled all of its Whole Milk Organic Powdered Infant Formula on 13 June 2026.

What is new is the FDA’s wider call for formula manufacturers and supply-chain partners to strengthen supplier verification and microbiological risk controls across the industry. [A]

The agency said recent events showed that risks may be introduced before ingredients reach the final formula manufacturer. Its investigation into the Nara and ByHeart outbreaks is continuing, and no single contamination route has yet been established for the current Nara outbreak.

Four infants have been affected in the Nara outbreak

As of the latest official update on 6 July, four infants with laboratory-confirmed infant botulism had been identified in California, Pennsylvania and Washington. Their illnesses began between April and May 2026.

All four infants had consumed Nara Organics Whole Milk Organic Infant Formula. All were admitted to hospital and treated with BabyBIG, the human botulism immune globulin used for infant botulism. No deaths had been reported. [B] [C]

Public-health laboratories detected Clostridium botulinum in an opened can of Nara formula collected from the home of one affected infant. The FDA has also collected an unopened sample from the same lot, but testing was still under way at the time of the latest update. [B]

A positive result from an opened container supports the investigation but does not, by itself, establish where or when the contamination occurred. Results from unopened products, ingredient testing, environmental investigations and supply-chain tracing remain important to determining the root cause.

Shared suppliers are being investigated, but causation is not established

The Nara formula lots consumed by the affected infants were made using milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America.

These companies were also suppliers of milk and milk powder connected with the earlier ByHeart investigation. However, the CDC and FDA have stated that the available evidence is not sufficient to conclude that either supplier caused the illnesses or was the route of contamination. [B] [C]

The distinction matters. A shared supplier may provide an important lead for investigators, but a connection in the supply chain is not the same as proof of contamination.

Which products have been recalled?

The recall covers all lots and both container sizes of Nara Organics Whole Milk Organic Powdered Infant Formula that were on the US market.

The formula was sold nationally through Target stores, Target.com and Nara.com between July 2025 and June 2026. It was not distributed outside the United States. [D]

Parents and caregivers should not use any Nara Organics infant formula, even when the lot number is not one of the initial lots linked to an affected infant.

The FDA has said Nara represents less than 1% of infant formula sold in the United States, and the recall is not expected to create a national formula shortage. [C]

What parents and caregivers should do

Parents should stop using recalled Nara formula immediately.

Unopened cans may be returned or discarded. For an opened can, the CDC recommends taking a photograph and recording the lot number and use-by date. The container should be clearly marked “DO NOT USE” and stored away from feeding supplies because health officials may request it for testing if the child develops symptoms. [E]

Items and surfaces that may have come into contact with the formula should be washed using hot soapy water or a dishwasher.

Parents should seek immediate medical care when an infant who consumed the recalled product develops signs such as:

• poor feeding or difficulty sucking;

• loss of head control;

• difficulty swallowing;

• a weak or altered cry;

• decreased facial expression;

• constipation or unusual floppiness;

• breathing difficulty.

Symptoms may take several weeks to appear. The CDC advises monitoring exposed infants for one month after they last consumed the recalled formula. [E]

Families developing a broader household safety plan may also find How to Prevent Poisoning at Home: A Parent's Essential Safety Guide useful for reviewing common exposure risks and practical prevention measures.

Why infant botulism is different from foodborne botulism

Infant botulism generally does not occur because a baby consumes toxin that has already formed in food.

Instead, the infant swallows Clostridium botulinum spores. The spores can colonise the immature intestine and produce neurotoxin inside the body. The toxin then interferes with acetylcholine release at neuromuscular junctions, causing progressive weakness and flaccid paralysis. [D] [E]

For additional background on how the toxin disrupts communication between nerves and muscles, An Interview with Botulinum Toxin: From the Deadliest Poison to a Miraculous Treatment explains the underlying toxicology and the medical uses of botulinum toxin.

Clinicians should not wait for laboratory confirmation

Initial diagnosis of infant botulism is clinical. A child may first present with constipation, poor feeding, weak cry, reduced facial movement, ptosis, impaired swallowing, hypotonia or loss of head control.

The CDC advises clinicians who suspect infant botulism to contact the Infant Botulism Treatment and Prevention Program immediately on 510-231-7600. Consultation is available 24 hours a day.

When clinical consultation supports the diagnosis, treatment should begin as soon as possible. Laboratory confirmation should not delay BabyBIG administration. Suspected cases should also be reported to the relevant state public-health department. [E]

Rapid communication and surveillance are particularly important when individual cases may form part of a wider exposure pattern. The role that specialist reporting systems play in identifying emerging toxicology signals is discussed in The Role of Poison Center Calls: Managing Poisoning Cases from Emergency Calls to Critical Decisions.

Recent human evidence shows why rapid outbreak detection matters

A 2026 multistate investigation published in NEJM Evidence examined the earlier ByHeart powdered formula outbreak.

Investigators identified 51 infants with suspected or confirmed botulism and exposure to ByHeart formula across 19 states. All required hospital admission, and no deaths were reported. Laboratory testing and whole-genome sequencing found genetic links between bacteria recovered from clinical samples, powdered formula and a milk-powder ingredient. [F]

The investigation did not evaluate a new treatment. Its main contribution was to show how clinical reporting, epidemiological investigation, product testing and genomic analysis can identify an unusual common-source outbreak that might otherwise appear to be a series of unrelated cases.

Established treatment evidence supports early BabyBIG administration

The evidence supporting BabyBIG is not new, but it remains central to the clinical response.

A randomised, double-blind, placebo-controlled trial involving 122 infants found that BIG-IV treatment reduced mean hospital stay from 5.7 weeks to 2.6 weeks. It also reduced time in intensive care, mechanical ventilation and tube or intravenous feeding. [G]

A later post-licensure study examined 1,192 infants treated between 2003 and 2015. Mean hospital stay was 2.2 weeks among treated patients, compared with 5.7 weeks in the historical placebo group. The greatest benefit was observed when treatment was given soon after hospital admission. [H]

These studies support rapid clinical recognition and early treatment, but they should not be described as discoveries arising from the current Nara outbreak.

What remains uncertain?

The complete source and route of contamination have not been established.

Testing of unopened Nara products was still in progress at the latest official update. Investigators were also continuing to examine ingredients, manufacturing facilities, supplier records and the possibility that other products might have been affected.

The presence of C. botulinum in an opened can is important evidence, but it does not yet determine whether contamination occurred during ingredient production, formula manufacturing, distribution, preparation or after the container was opened.

No company or supplier should be described as the confirmed source unless the FDA or another responsible public-health authority publishes sufficient evidence.

What is genuinely new?

The clearly identifiable new development is the FDA’s 13 July 2026 industrywide call for stronger supplier oversight.

The agency has moved the discussion beyond an individual product recall and asked formula manufacturers and their supply-chain partners to improve traceability, hazard assessment, monitoring and responses to safety signals. [A]

The following information is important but is not new:

• the Nara recall began on 13 June;

• the four-case outbreak count was published on 6 July;

• the clinical signs of infant botulism are established medical knowledge;

• the evidence supporting BabyBIG comes from earlier clinical research;

• clinicians have long been advised not to delay treatment while waiting for laboratory confirmation.

There is no newly published treatment trial or diagnostic test arising from the Nara outbreak at this time. The news value comes from the new FDA supply-chain action and the continuing outbreak investigation.

A wider safety question remains

The FDA’s communication signals that the public-health response is shifting from removing individual recalled products to examining how formula ingredients are sourced and monitored across the industry.

For families, the immediate instruction is specific: do not use recalled Nara formula and seek urgent assessment if an exposed infant develops compatible symptoms.

For clinicians, early recognition and prompt BabyBIG consultation remain the most important actions.

For regulators and manufacturers, the larger question is whether supplier oversight and traceability systems can identify microbiological risks before contaminated ingredients reach vulnerable infants.

The investigation remains open, and conclusions about its root cause should wait for further testing.

References

A. U.S. Food and Drug Administration. (2026, July 13). FDA calls on infant formula industry to better safeguard against contaminants introduced through their supply chain.

B. Centers for Disease Control and Prevention. (2026, July 6). Investigation update on infant botulism outbreak, June 2026.

C. U.S. Food and Drug Administration. (2026, July 6). Outbreak investigation of infant botulism: Powdered infant formula—June 2026.

D. Nara Organics. (2026, June 13). Nara Organics recalls all lots of Nara infant formula because of possible health risk. U.S. Food and Drug Administration.

E. Centers for Disease Control and Prevention. (2026, July 6). Infant botulism outbreak linked to powdered infant formula, June 2026.

F. Chung, C. H., Barash, J. R., Castonguay, J. L., Penzel-McNamara, C., Lee, K., Read, J. S., Padgett, K. A., Dover, N., Judson, A. J., Lamere, L., Taylor, E. V., Cope, J. R., Conrad, A., Medford, R., Brooks, M., Whitlock, L., Dykes, J., Lúquez, C., Bracken, J. M., . . . Khouri, J. M. (2026). Multistate infant botulism outbreak associated with powdered infant formula. NEJM Evidence, 5(4), EVIDpha2600020.

G. Arnon, S. S., Schechter, R., Maslanka, S. E., Jewell, N. P., & Hatheway, C. L. (2006). Human botulism immune globulin for the treatment of infant botulism. The New England Journal of Medicine, 354(5), 462–471.

H. Payne, J. R., Khouri, J. M., Jewell, N. P., & Arnon, S. S. (2018). Efficacy of human botulism immune globulin for the treatment of infant botulism: The first 12 years post licensure. The Journal of Pediatrics, 193, 172–177.