Infant formula urgently recalled over non-compliance with US federal regulations

Dairy Manufacturers Inc. has pulled all of its infant formula products from the US market after the manufacturer failed to comply with the Food and Drug Administration’s registration requirements.

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

The company had not submitted the required pre-market notification, the regulator said in a statement, which means the FDA had not been able to check if the products meet food safety and nutritional standards.

As a result, all lot codes of Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose have been recalled. The products were only sold in Texas at retail level, the manufacturer claims.

Consumers who had purchased any of these products are told to discontinue their use and return them for a full refund. No reports of illness due to the consumption of the products have been received, the FDA 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,” Dairy Manufacturers Inc. said in a statement.

How did the infant formula maker breach regulations?

According to the recall notification, Dairy Manufacturers Inc. failed to comply with the registration requirements listed in section 21 CFR 106.110​.

The clause states that before a new infant formula is brought to market, the manufacturer must register with the FDA. Makers must provide the following details to the federal agency:

• the name of the new infant formula;
• the name of the manufacturer;
• the street address of the place of business of the manufacturer; and
• the name and street address of each establishment at which the manufacturer intends to manufacture such new infant formula.

Manufactures must notify the FDA of their intentions to launch a new infant formula at least 90 days in advance and must provide assurances that the product would not be marketed unless it complies with federal regulations regarding safety and nutritional standards. 

According to the FDA, if an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated and the regulator can take compliance action - including a mandatory recall.

There are 30 nutrients that must be included in infant formula to comply with FDA regulations.

The recalled products are: