Dairy Manufacturers Inc. Issues Voluntary Recall of Baby Formula

In a significant move, Dairy Manufacturers Inc., a Texas-based company, has initiated a voluntary recall of several baby formula products after they were found to be noncompliant with U.S. Food and Drug Administration (FDA) regulations. The recall encompasses all lot codes of three specific products: Farmalac 0-12, Farmalac 0-12 Low Lactose, and Crecelac Infant 0-12. This announcement was officially published on the FDA’s website on Saturday.

Consumers who have purchased Crecelac Infant 0-12, Farmalac 0-12, or Farmalac 0-12 Low Lactose are advised to discontinue their use immediately. They should return the products to the place of purchase for a full refund. For further assistance, customers can contact Dairy Manufacturers Inc. at 1-972-347-2341, available Monday through Friday from 9:30 a.m. to 5 p.m. ET.

These infant formula products were exclusively sold in retail stores across Texas and were packaged in 12.4-ounce cans made of cardboard and aluminum, with expiration dates set for August and September 2025. Importantly, no illnesses or adverse reactions have been reported in connection with the recalled products to date. However, the FDA has emphasized that these formulas have not been evaluated to ensure they meet U.S. food safety and nutritional standards.

The core issue prompting this recall is the company’s failure to comply with the FDA’s stringent requirements for infant formula. According to section 21 of the FDA’s Code of Federal Regulations, manufacturers and distributors of new infant formulas must register with the FDA and submit a premarket notification before their products can be sold across state lines. Dairy Manufacturers Inc. did not fulfill this requirement, resulting in the recall of the aforementioned products.

Product recalls are a critical measure to protect consumers from potential harm, often triggered by contamination risks, mislabeling, or failure to meet nutritional standards. This recall follows another recent incident where a Washington-based company recalled a Goat Milk Formula Recipe Kit on FDA advice due to insufficient nutritional content for use as an infant formula.

The company has expressed regret for any inconvenience caused and assured customers that they are taking all necessary steps to ensure the safety, quality, and compliance of their products moving forward.