Crecelac and Farmalac-branded infant formula is being recalled after being placed on shelves without proper evaluation by the Food and Drug Administration (FDA).
Dairy Manufacturers Inc. issued a voluntary recall for all lot codes of formulas available in the U.S. including Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose at the retail and wholesale level.
According to a notice posted by the FDA, the products “were sold in the U.S. without complying with the FDA’s infant formula regulations.”
The FDA notified the company after realizing Dairy Manufacturers didn’t submit the required pre-market notification.
“Parents and caregivers should understand that the products have not been evaluated by FDA to determine whether they meet U.S. food safety and nutritional standards,” the recall notice read.
The affected products were labeled as infant formula and packaged in a cardboard and aluminum 12.4-ounce can.
They were sold at retail stores in Texas, though the notice didn’t specify which stores.
Although no known injuries or adverse reactions were reported, consumers “are urged to discontinue use of the recalled products and return it to the place of purchase for a full refund,” according to the recall warning.
Consumers with concerns are urged to talk to health care providers, the notice said.
“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.