Manufacturers Crecelac and Farmalac are recalling all US infant formulas

Dairy Producers Inc. has withdrawn all of its infant formula products from the U.S. market after the manufacturer failed to meet Food and Drug Administration registration requirements.

Prosper, Texas-based Dairy Producer Inc., which also produces milk replacer and supplements for cattle, pets and small species, sold the products without complying with FDA regulations for infant formula.

As the regulator said in a statement, the company failed to provide required pre-market notification, meaning the FDA was unable to check whether the products met food safety and nutritional standards.

As a result, all Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose series codes have been withdrawn. The manufacturer claims that the products were sold in Texas only in retail form.

Consumers who have purchased any of these products are advised to discontinue use and return them for a full refund. The FDA said it has not received any reports of illness caused by consuming these products.

“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,” Dairy Producers Inc. said. in a statement.

How did a manufacturer of infant formula violate the regulations?

According to the recall notice, Dairy Producers Inc. has failed to meet the registration requirements set forth in Section 21 CFR 106.110​.

The clause states that before a new infant formula can be placed on the market, the manufacturer must register with the FDA. Creators must provide the federal agency with the following information: