After advising a baby formula manufacturer to take its products out of circulation in May 2024, the FDA has now categorized the baby formula as a Class 1 recall, the most severe recall category. The formula contains deadly bacteria.
Consequently, the FDA is calling on parents to immediately get rid of the baby formula to avoid the risk of death.
The Recall
On May 10, Healthwest Mineral, the manufacturer of a Goat Milk Formula Recipe Kit, began a recall of the product. Earlier, the FDA had issued a recall recommendation to the manufacturer, implicating 1506 boxes of the product that had already penetrated the market.
The FDA cited a lack of regulatory compliance from the company as the reason for the action.
A Breach of Due Process
According to the explanation from the FDA, “The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but the product has not submitted to FDA the premarket notification required for an infant formula for review.”
In a nutshell, the product had breached due process. Interestingly, the product had already enjoyed one year in the market. It is sold through Mt. Capra’s web store and another retail store based in Washington.
The FDA Stumbled on a More Alarming Discovery
Afterward, upon further scrutiny, the regulator discovered that the product fell short of the requirements for infant formula. Simply put, the product offered insufficient nutrition.
As a result, infants who consumed the product were at risk of iron deficiency, anemia, and feeding intolerance. At the time, there was already a report of a baby diagnosed with anemia after taking the product.
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Infants Below the Age of One Are Especially at Risk
A warning also went out to parents concerning an age bracket that is primarily at risk of harm. “The firm does not recommend using this product for infants from 0-12 months of age,” the FDA stated.
“If you have prepared and fed your infant Mt. Capra formula from their Goat Milk Formula Recipe Kit, we recommend you contact a healthcare provider to discuss if testing for nutritional deficiencies is recommended.”
A Life-Threatening Bacteria
Amongst other baby formula recalls issued this year is the Crecelac brand formula. The manufacturer of this product, Dairy Manufacturers Limited of Prosper, Texas, has begun recalling the product since May 24.
The FDA announced that Crecelac and a sister product from the same company, Farmalac, had “not been evaluated by [the] FDA to determine whether they meet U.S. food safety and nutritional standards.” Later, the FDA began to suspect a dangerous and fatal bacteria hidden in Crecelac.
Cronobacter
The firm announced to consumers that Crecelac likely contains a deadly bacteria called Cronobacter Sakazakii. Symptoms of Cronobacter infection in affected children include irritability, jaundice, temperature changes, poor feeding, abnormal body movements, and grunting breaths.
The FDA advised parents who notice these symptoms to report to a physician immediately. The earlier parents report such cases, the better their child’s chances of survival.
The FDA’s Statement Continues
Furthermore, the FDA’s press release described Cronobacter as “a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively.”
Speaking on the consequences of the bacterium in the system of children under the age of 1, the statement revealed that “Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.”
No Cronobacter in Farmalac
Although from the same manufacturer, the Farmalac products have a less serious challenge. The Farmalac baby powdered infant formula with iron 0-12 months and the Farmalac baby powdered infant formula with iron low lactose 0 – 12 months do not contain the bacteria.
However, the FDA recalled them for the same reason as the Goat Milk Formula Recipe Kit— “because of their failure to meet U.S. infant formula regulations.”
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More Information for Parents
In addition to stopping use, the FDA has encouraged parents who have already bought the products to return them to the stores where they made the purchase as soon as possible. When they do, they will get a full refund of the cost.
Buyers aren’t alone. They can contact the FDA at 1-972-347-2341. Furthermore, parents in search of an alternative goat milk infant formula should consult with their child’s health care provider.
Sammy’s Milk
Another Goat Milk Baby Formula that had to go out of circulation was Sammy’s Milk Goat Milk Little Toddler Formula. On April 18, the FDA issued an advanced warning to the California-based manufacturer against the consumption of its product.
The reason for the move was “identified representations on the Sammy’s Milk website and social media platforms that could be interpreted to indicate the product is safe for infants to consume.”
Nutramigen Powder
Nutramigen Powder was also affected by the wave of baby milk formula recalls. Reckitt/Mead, the formula’s producers, issued a recall order on December 30, 2023, for its 12.6—and 19.8-ounce containers.
The reason? Possible contamination with the C. sakazakii bacteria. The company made the affected products in June, July, and August 2023. They expire on January 1, 2025.
Other Affected Products
Other products that suffered the same fate include the Gerber Good Start SoothePro Powdered Infant Formula. Its manufacturer, the Perrigo Company, issued a recall order on March 17 after receiving a prompt from the FDA over a suspected C. sakazakii contamination.
The other implicated products are the Gerber Good Start from Associated Wholesale Grocers Inc. and Enfamil ProSobee from Reckitt.
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