The FDA has asked Sammy’s Milk of Newport Beach, CA, to provide a warning against the use of its toddler formula as an infant formula.

The agency is concerned that the formula may not meet requirements for infant formula and may be unsafe and not provide sufficient nutrition when used as an infant formula.

The FDA’s concerns were provided to Sammy’s Milk in a meeting with agency officials this week that 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.

The company says its product is specifically formulated for children between the ages of 12 and 36 months, as clearly indicated on its packaging and website. The product at issue was only available online, and included lot code SD348, with a “Best by” date of August of 2025.

“It is crucial that users adhere to the recommended age range for the consumption of our product. Sammy’s Milk does not recommend the use of Goat Milk Toddler Formula for infants under 12 months of age. If you are feeding our product to an infant, we recommend that you stop doing so because the FDA has concerns that Goat Milk Toddler Formula does not meet all FDA requirements for infant formula and may be unsafe and not provide sufficient nutrition when used as an infant formula,” the company said in a statement posted by the FDA.

“For further inquiries or clarification regarding the appropriate use of Sammy’s Milk Goat Milk Toddler Formula, please contact our customer service team at info@sammysmilk.com.”

In 2016 the company recalled all lots of Sammy’s Milk Baby Food because of the possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal blood infections or meningitis in infants.