A recall of all of Sammy’s Milk Baby Food products in 12.84-ounce plastic containers with expiration dates of November 2016 through August 2018 has been issued. The powdered infant formula product is sold online and in California Mother’s Market & Retail stores.
While there have not been any reports of adverse effects experienced by infants who have consumed the recalled product, the FDA is advising consumers not to purchase Sammy’s Milk Baby Food.
Falls short of nutrient requirements and bacteria testing
One of the FDA’s major concerns over Sammy’s Milk Baby Food is that it has not been tested for Cronobacter, a bacterium that can cause severe and sometimes fatal blood infections or meningitis in infants. The product also may not provide adequate nutritional levels of iron, according to the FDA recall statement.
All infant formula products sold in the US are required to be tested for 30 key nutrients, including iron. According to the FDA, Sammy’s Milk Baby Food contains 0.2 mg of iron per serving (i.e., per 100 calories or per 120 ml), which is equivalent to 1.67 mg of iron per liter,well below the iron content of 4 to 8 mg/L that formula-fed infants up to six months of age should receive. Infant formula products that contain less than 1 mg of iron per 100 calories are required to include a statement on the label indicating that additional iron may be necessary.
“If you fed your infant Sammy’s Milk Baby Food and think they are suffering from Cronobacter infection or iron deficiency anemia, contact a healthcare provider immediately,” the FDA said in its recall warning advisory.
How does the FDA regulates infant formula?
The FDA applies the same laws and regulations governing food products to infant formula products, but with additional statutory and regulatory requirements, because it is typically the sole source nutrition for infants during a critical period of growth and development.
The FDA does not approve infant formulas before they can be marketed. However, all formula marketed in the US must meet federal manufacturing and nutrient requirements. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.