Dairy Manufacturers Recalls Baby Formula Products Due to FDA Noncompliance

There have been no reported injuries or adverse reactions due to consumption of the products to date.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Dairy Manufacturers Inc. has announced that it was recalling several of its baby formula products that had been found noncompliant with U.S. Food and Drug Administration (FDA) regulations.

The Texas-based dairy company is recalling all lot codes for Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose, according to a company statement published on the FDA’s website on May 25.

These infant formula products are packaged in 12.4-ounce aluminum cans and cardboard, with expiration dates set for August and September 2025. They were sold exclusively in retail stores across Texas.

“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,” it stated.

Dairy Manufacturers said the products were recalled because they were distributed in the United States without adhering to the FDA’s infant formula regulations, which require manufacturers of new infant formulas to register with the regulatory agency.

This issue was identified following an FDA notification as the company failed to submit the required premarket 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 company stated.

There have been no reported injuries or adverse reactions due to consumption of the products to date, according to the statement.

Dairy Manufacturers advised consumers who have bought the recalled products to discontinue their use and return them to the place of purchase for a full refund.

Another Baby Milk Recalled

This follows the recall of 1,506 boxes of Goat Milk Formula Recipe Kit by Healthwest Minerals Inc.—doing business as Mt. Capra Products—which was prompted by the FDA recommendation due to its insufficient nutritional when used as infant formula.

The Goat Milk Formula Recipe Kit 10-pound eight ounces was sold at Mt. Capra’s store in Chehalis, Washington, and on its website from May 1, 2023, to May 1, 2024.

One infant developed anemia after being fed with the product.

“Infants consuming the recalled product without additional iron supplementation can develop iron deficiency anemia and feeding intolerance,” the company stated on the FDA’s website on May 10.

The FDA found that “while the caregivers were using the Goat Milk Formula Recipe Kit and recipe, the caregivers substituted some ingredients with a different brand of multivitamin, which created a product deficient in vitamin B12 as well as folate and ultimately resulted in the development of anemia.”

Mt. Capra stated that it does not recommend using the recalled product for infants aged 0-12 months and advised those who have prepared and fed their infant with formula from the Goat Milk Formula Recipe Kit to contact a healthcare provider for consultation.