Dairy Manufacturers Inc. has issued a voluntary recall of its Crecelac and Farmalac-branded infant formulas. The recall, announced on Thursday, comes after it was discovered that these products were sold without the necessary evaluation by the Food and Drug Administration (FDA), thereby failing to comply with federal regulations.
The recall encompasses all lot codes of Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose formulas sold at both retail and wholesale levels in Texas. According to an FDA notice, the products "were sold in the U.S. without complying with the FDA's infant formula regulations," indicating that Dairy Manufacturers did not submit the required pre-market notification.
Parents and caregivers have been advised to cease using these products immediately. "The products have not been evaluated by FDA to determine whether they meet U.S. food safety and nutritional standards," the recall notice emphasized. The formulas were packaged in 12.4-ounce cans made of cardboard and aluminum and were available at various retail stores throughout Texas, though specific locations were not disclosed.
Despite the regulatory oversight, no injuries or adverse reactions have been reported. Nevertheless, consumers are urged to return the products to the place of purchase for a full refund. The company has expressed regret for the oversight and the inconvenience it may cause. "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 stated.
The specific products under recall include Crecelac Infant 0-12 with UPC 8 50042 40847 6, and Farmalac 0-12 with UPC 8 50042 40841 4, as well as Farmalac 0-12 Low Lactose with UPC 8 50042 40839 1, all with expiration dates of August 2025 and September 2025.
This recall highlights the critical importance of regulatory compliance in the production and sale of infant formula, a product essential for the health and development of infants. The FDA has stringent requirements to ensure that all infant formulas meet specific nutritional and safety standards. These standards are in place to protect the youngest and most vulnerable consumers.
Dairy Manufacturers' failure to comply with these requirements underscores the necessity for vigilance and adherence to established protocols. The FDA's pre-market notification process is designed to evaluate the safety and nutritional adequacy of new infant formula products before they reach consumers. Without this evaluation, the safety and nutritional value of the formula cannot be guaranteed.
While the recall is limited to Texas, the incident serves as a reminder to manufacturers nationwide about the importance of compliance with FDA regulations. It also underscores the role of regulatory bodies in safeguarding public health, particularly for products that are critical to infant care.
Consumers who have purchased the recalled products should contact their healthcare providers if they have any concerns about potential health impacts. The FDA's notice reassures the public that there have been no reported illnesses related to the consumption of these formulas, but caution and proactive measures are encouraged.
The recall process itself is a robust mechanism designed to quickly address potential safety issues. By issuing a voluntary recall, Dairy Manufacturers is taking responsibility and working to mitigate any potential risks associated with their products. This swift action is essential in maintaining public trust and ensuring the continued safety of consumers.
