Baby Formula Maker Nara Issues US-Wide Recall After FDA, CDC Flag Infant Botulism Cases

IMT News Desk
IMT News Desk
· 3 min read
Nara Organics recalls all US infant formula after the FDA/CDC flagged 3 infant botulism cases in CA, PA, WA; no deaths, all babies treated with antitoxin.

Baby formula manufacturer Nara Organics has announced a voluntary recall of all its infant formula products currently on the market in the United States due to a potential risk of bacterial contamination following alerts from federal health authorities about infant botulism cases linked to the product.

On Friday, June 12, 2026, the U.S. Food and Drug Administration (FDA) and Center for Disease Control (CDC) contacted Nara Organics late in the evening and provided information about three cases of infant botulism in infants who CDC reported had consumed Nara formula, with the three infants hospitalized and treated with BabyBIG (Botulism Immune Globulin Intravenous) in California, Washington, and Pennsylvania.

The recalled product is Nara Organics Whole Milk Organic Powdered Infant Formula, which was distributed nationally across Target retail stores, Target.com and Nara.com from July 2025 to June 2026, encompassing all varieties of the formula sold nationwide.

The three specific product lots that the infants were exposed to include batch numbers 709125280E14F2, 709125288E14F2, and 708125174E14F2, which were identified through CDC epidemiological investigation.

To date, Nara infant formula has not tested positive for Clostridium botulinum bacteria; however, Nara is voluntarily recalling all products currently in the market out of an abundance of caution due to the potential risk of Clostridium botulinum contamination.

The three infants who developed infant botulism were aged between 2 and 5 months and contracted the illness between April and May 2026 in California, Pennsylvania, and Washington, with all 3 babies receiving hospitalization and treatment with botulism antitoxin.

Fortunately, the CDC has confirmed that there have been no reported deaths linked to these cases, with the agency advising individuals who possess the formula to discontinue its use immediately.

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of three confirmed or suspected infant botulism illnesses from three states.

On June 12, 2026, the FDA contacted the firm to notify them about this outbreak and recommended that the firm conduct a recall due to the severity of illness and the epidemiological signal, with Nara Organics agreeing to recall all of their product on June 13, 2026.

The CDC recommended that consumers label the recalled formula as ‘DO NOT USE’ and store it safely away from other items meant for babies for at least a month to ensure it is not accidentally consumed.

This recall follows a similar incident in November 2025 when federal and state health authorities investigated 13 cases of infant botulism across 10 U.S. states linked to another recalled baby formula, highlighting the ongoing vigilance needed for infant product safety.

Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria that can produce toxins affecting the nervous system, requiring immediate medical treatment with botulism antitoxin to prevent severe complications.

The FDA continues to monitor the situation closely and will provide updates as more information becomes available regarding the multistate outbreak investigation and any additional safety measures that may be necessary.

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