Enforcement WeeklyRegister of FDA actions · supplements, cosmetics, food
Records as of 2026-09-28 · 202 actions this year · not affiliated with the FDA

Class I · Recall · initiated June 13, 2026 · Ongoing

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Nara Organics recalls 377,610 cans of organic infant formula over botulinum risk

Nara Organics of New York recalled 377,610 cans of its Whole Milk Organic Infant Formula, in 700 g and 400 g sizes sold nationwide, because the powder may be contaminated with Clostridium botulinum.

The record

Firm
Nara Organics Inc, New York, NY
Product
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918
Reason, as filed
“Product may be contaminated with Clostridium botulinum.”
Classification
Class I (Class I: reasonable probability of serious health consequences or death)
Recall number
H-1137-2026
Initiated
June 13, 2026
Posted by FDA
July 8, 2026
Status
Ongoing · Voluntary: Firm initiated
Quantity
377,610 cans
Distribution
nationwide

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Why it happened, in plain English

The filed reason says the product “may be contaminated with Clostridium botulinum.” The record does not say what prompted the recall: a positive test, an illness report, a supplier notice, or a finding in the plant. It does not name a manufacturer, and the product description lists only the Nara Organics brand. What it does show is scale: 377,610 cans, nationwide, two package sizes, one brand.

Infant formula is the highest-consequence product in the food code. In general terms, C. botulinum spores in a powdered formula are a concern because infants under one year cannot handle the spores the way older children can, which is the same reason honey is kept away from babies. Spores survive drying and survive in powder. For a formula brand, that puts the burden on the supply chain for every dairy and dry ingredient and on the maker’s environmental and finished-product testing, none of which the record describes.

Who else should care

Infant formula and toddler nutrition brands, especially small organic or specialty brands that own the label but not the plant. When a recall of this size is filed under the brand’s name, the brand carries it, whatever the arrangement with the manufacturer.

Brands in adjacent categories, such as infant cereals, baby-food powders and nutritional powders for children, should read this as a reminder that spore-forming organisms are a separate hazard from the pathogens most powder programs already test for. Check: whether your hazard analysis for powdered infant products names Clostridium botulinum specifically and states which control addresses it.

Written 2026-09-08. Analysis is editorial; the record above is FDA's.