Texas-based company is recalling baby formula products after they were found to be in noncompliance with the U.S. Food and Drug Administration’s (FDA) requirements.
Dairy Manufacturers Inc., of Prosper, announced a voluntary recall of all lot codes for three infant formula products available in the U.S.: Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose. The FDA published the company’s announcement on its website on Saturday.
The products have been recalled because they were sold in the U.S. without complying with the FDA’s infant formula requirements. They were sold in violation of section 21 of the agency’s Code of Federal Regulations, which requires those responsible for the manufacture or distribution of a new infant formula to register with the FDA before the product can be introduced to interstate commerce.
“This was identified after an FDA notification, because the firm has not submitted the required premarket notification,” the announcement said.
“Parents and caregivers should understand that the products have not been evaluated by [the] FDA to determine whether they meet U.S. food safety and nutritional standards.”
No illnesses have been reported to date in relation to the recalled products, the announcement said.
The products in question are labeled as infant formula, packaged in a cardboard and aluminum 12.4-ounce cans with expiry dates in August and September 2025. They were only sold in retail stores in Texas.
Consumers who purchased Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low Lactose are urged to stop using the recalled products and return them to the place of purchase for a full refund.
The company said that there have been no known reports of illnesses or adverse reactions due to consumption of these products, but anyone with concerns about an illness should contact a health care provider.
“We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality and compliance of our products,” the company said.
Customers with questions can contact the company on 1-972-347-2341, Monday to Friday, between 9:30 a.m. and 5 p.m. ET.
Recalls are usually issued if there are concerns that a product may be harmful to consumers in some way, such as if products may be contaminated or if mislabeled products fail to disclose allergens.
Earlier this month, a company based in Washington recalled a Goat Milk Formula Recipe Kit on the advice of the FDA because the product does not provide sufficient nutrition when used as infant formula.
