FDA Class I recall: infant formula that may be contaminated with Clostridium botulinum — 377,610 cans nationwide (nara organics)
The U.S. Food and Drug Administration (FDA) classified nara organics brand organic infant formula (milk-based powder with iron, for 0-12 months) as a Class I recall, its most serious category, because the product may be contaminated with Clostridium botulinum. The recall covers 377,610 cans distributed nationwide.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeFood
- Recalling firmNARA ORGANICS INC
- ReasonProduct may be contaminated with Clostridium botulinum.
- Distributionnationwide
- Recall initiated2026-06-13
Key points
- The FDA classified it Class I, its most serious category (H-1137-2026, reported July 8, 2026, status ongoing).
- The products are nara organics brand organic infant formula (milk-based powder with iron, 0-12 months) in 24.7 oz and 14.1 oz cans.
- The stated reason is that the product may be contaminated with Clostridium botulinum.
- The quantity is 377,610 cans distributed nationwide; the voluntary, firm-initiated recall began June 13, 2026.
- Infants under one year have a still-developing gut flora, so spores can colonize the intestine and produce toxin — the condition known as infant botulism.
1Why this is the most serious class
Class I is the most serious of the FDA's recall classifications. It applies when there is a reasonable probability that using or being exposed to a product will cause serious harm to health or death. The product here is infant formula consumed as the primary food by babies aged 0 to 12 months — an age group with few substitutes — which is the starting point for understanding why the classification is this severe.
2What infant botulism is
Clostridium botulinum is a bacterium that grows in low-oxygen environments and can produce a potent neurotoxin. In infants under one year of age the balance of gut bacteria is still developing, so spores (the dormant form of the bacterium) present in food can germinate and colonize the intestine, where toxin may then be produced in the body.
This condition is known as infant botulism, and it is recognized by changes such as constipation, weak feeding, a weak cry, and poor head control. The widely repeated advice not to give honey to infants rests on the same spore risk.
3Why powdered formula is not sterile
A second piece of background is that powdered infant formula is, by the nature of its manufacturing process, not a sterile product. Unlike liquid formulations, powder cannot be heat-sterilized after it is filled into the container, so hygiene control over ingredients and the production environment — along with water temperature and handling during preparation — carries the safety burden.
That structure is why microbial contamination of powdered formula has repeatedly been treated as a serious recall.
4The scale: 377,610 cans nationwide
The scale is also notable: 377,610 cans distributed nationwide. Infant formula buyers are not concentrated in particular stores or regions, and the product is often stocked up in advance, so whether recall notices reach the caregiver at the end of the chain largely determines how effective the recall is.
FDA records show the recall began as voluntary and firm-initiated, and that the company used two or more of the following notification methods: email, fax, letter, press release, telephone, and visit.
Why it matters
Infant formula combines three conditions — the consumers are babies, substitutes are limited, and the product is distributed nationwide and often stocked up — so whether the notice reaches the final purchaser largely determines a recall's effectiveness. Powdered formula is a category that cannot be heat-sterilized after filling, which makes hygiene control over ingredients and the production environment, lot-level traceability, and notification paths across both retail and e-commerce the practical priorities for preparing for this kind of recall.
FAQ
How serious is a Class I classification?
Why is Clostridium botulinum a particular concern for infants?
Which products are covered?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: H-1137-2026