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FDA Investigates Presence of Mucormycosis-causing Mold in Infant and Children’s Probiotic Supplement

Update

December 10, 2014

On November 22, 2014, FDA scientists confirmed the presence of Rhizopus oryzae from unopened containers of Solgar ABC Dophilus Powder, which had been collected at the hospital where the preterm infant died.

On December 9, 2014, the FDA alerted healthcare providers about the risks of using dietary supplements formulated to contain live bacteria or yeast in people with compromised immune systems. The letter also encouraged health care providers who use dietary supplements containing live bacteria or yeast as drugs (e.g., to treat, mitigate, cure, or prevent a disease or condition) to submit an Investigational New Drug Application for FDA review.

Posted December 10, 2014

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The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health are investigating the death of a preterm infant who suffered from gastrointestinal mucormycosis. The CDC has determined that the mucormycosis was caused by the mold species Rhizopus oryzae. 

ABC Dophilus® Powder, sold by Solgar Inc. of Leonia, New Jersey, was used as part of the in-hospital course of treatment for the infant. The CDC confirmed that mold present in an unopened container of the powder was Rhizopus oryzae, which can cause mucormycosis.

Solgar Inc. recalled three production batches, or lots, of the product on November 14, 2014.

What is the Problem and What is Being Done About It?

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health are investigating the death of a preterm infant who suffered from gastrointestinal mucormycosis. Gastrointestinal tissue from the infant underwent laboratory testing at CDC which revealed invasive mucormycosis due to the mold Rhizopus oryzae.

ABC Dophilus® Powder, sold by Solgar Inc. of Leonia, New Jersey, was used as part of the in-hospital course of treatment for the preterm infant who died October 11, 2014.

Testing conducted locally revealed the presence of mold in unopened 1.75oz (50g) containers of Solgar ABC Dophilus Powder.

This mold was confirmed by the CDC as Rhizopus oryzae, which can cause mucormycosis. CDC provided this information to the FDA on November 12, 2014.

The FDA, which has been investigating the incident since October 31, presented Solgar Inc. with this information and the company recalled certain lots of the product on November 14, 2014. Distribution of this product has been suspended and the FDA is continuing its investigation.

On November 22, 2014, FDA scientists confirmed the presence of Rhizopus oryzae from unopened containers of Solgar ABC Dophilus Powder, which had been collected at the hospital where the preterm infant died.

On December 9, 2014, the FDA alerted healthcare providers about the risks of using dietary supplements formulated to contain live bacteria or yeast in people with compromised immune systems. The letter also encouraged health care providers who use dietary supplements containing live bacteria or yeast as drugs (e.g., to treat, mitigate, cure, or prevent a disease or condition) to submit an Investigational New Drug Application for FDA review.

What is the Problem and What is Being Done About It?

Gastrointestinal Mucormycosis is a rare, but life-threatening fungal infection that can affect any part of the gastrointestinal tract. 

Who is at Risk?

Gastrointestinal Mucormycosis primarily affects people with weakened immune systems, including infants born prematurely.

What are the Symptoms of Gastrointestinal Mucormycosis?

Gastrointestinal symptoms of mucormycosis include abdominal pain, fever, nausea, and vomiting. Infection is acute and often rapidly fatal.

What Specific Items were Recalled? 

Solgar Inc. of Leonia, New Jersey has recalled certain lots of ABC Dophilus® Powder. It is sold in containers through pharmacies, retail stores, wholesale, and on the internet. Solgar Inc. reports that this product was distributed to Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Michigan, Maine, Massachusetts, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Utah, Tennessee, Texas, Vermont, Kentucky, Wisconsin, Washington, the United Kingdom and Israel. 

ProductSizeUPC CodeLot NumbersExpiration Date
ABC Dophilus® Powder1.75 oz. (50 G)0 33984 00010 0074024-01R1, 074024-01, 074024-027/31/15

What Do Consumers Need To Do?  

The FDA recommends that consumers not use ABC Dophilus Powder with the affected lot codes.

Consumers should see if they have ABC Dophilus ® Powder with the recalled lot codes. If they do, they should not use the products.

Consumers who have purchased the recalled product should return it to the place of purchase for a full refund. 

Who Should be Contacted? 

Consumers with questions may contact Solgar Inc. at 888-534-6370, Monday-Friday, 9AM-7PM ET.

The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or consult the fda.gov website: http://www.fda.gov.  


The information in this posting reflects the FDA’s best efforts to communicate what it has learned from the manufacturer, the CDC, and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available. 

FDA Safety Alert

CDC Web Post

Solgar Press Release

CDC Information: Mucormycosis

Page Last Updated: 11/03/2016
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