Infant formula withdrawn from sale due to non-compliance with FDA regulations

Crecelac and Farmalac brand infant formulas are being recalled after being placed on shelves without proper review by the Food and Drug Administration (FDA).

Dairy Producers Inc. has voluntarily withdrawn all lot codes of products available in the US, including Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low Lactose, at the retail and wholesale levels.

According to a notice published by the FDA, the products “were sold in the U.S. without compliance with FDA regulations for infant formula.”

The FDA notified the company after it became aware that dairy product manufacturers had failed to provide required premarket notification.

“Parents and guardians should understand that the products have not been evaluated by the FDA to determine whether they meet U.S. food safety and nutritional standards,” the recall notice reads.

The affected products were labeled as infant formula and packaged in a 12.4-ounce cardboard/aluminum can.

They were sold at retail stores in Texas, although the notice did not specify which stores.

While no known injuries or adverse reactions have been reported, consumers are encouraged to “stop using the recalled products and return them to the place of purchase for a full refund,” the recall alert reads.

The notice said consumers with concerns should talk to their health care providers.

“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.