Recall Issued for Crecelac and Farmalac-Branded Infant Formula Due to Lack of FDA Evaluation

Crecelac and Farmalac-branded infant formulas are being recalled after being placed on shelves without proper evaluation by the Food and Drug Administration (FDA).

Dairy Manufacturers Inc. has issued a voluntary recall for all lot codes of Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose formulas at both retail and wholesale levels across the U.S.

Reason for Recall

According to an FDA notice, these products "were sold in the U.S. without complying with the FDA’s infant formula regulations." The recall was initiated after the FDA notified Dairy Manufacturers Inc. that the required pre-market notification had not been submitted. This step is crucial for ensuring that all infant formulas meet U.S. food safety and nutritional standards before reaching consumers.

Products Affected

The recall includes the following products:

1. Crecelac Infant 0-12

2. Farmalac 0-12

3. Farmalac 0-12 Low Lactose

These products were packaged in 12.4-ounce cans made of cardboard and aluminum. They were sold at retail stores in Texas, although the recall notice did not specify which stores carried the products.

Safety Concerns

"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 recall notice stated. This lack of evaluation means there is no assurance that these formulas provide the necessary nutrients for infants or that they are free from harmful contaminants.

Consumer Advisory

Although no known injuries or adverse reactions have been reported, the FDA and Dairy Manufacturers Inc. urge consumers to discontinue use of the recalled products immediately. The recall notice advises consumers to return the products to the place of purchase for a full refund.

Consumers with concerns are advised to consult health care providers to ensure the health and safety of their infants. The FDA emphasizes the importance of using only those infant formulas that have been properly evaluated and approved.

Visual Identification

Here are images of the recalled products to assist consumers in identifying them:

Steps for Consumers

1. Check Your Inventory: Ensure you do not have any of the recalled products in your home.

2. Discontinue Use: If you have the recalled formulas, stop using them immediately.

3. Return the Products: Take the recalled products back to the place of purchase to receive a full refund.

4. Consult Health Care Providers: If you have used the recalled products and have concerns about your child’s health, seek advice from your health care provider.

Company Response

Dairy Manufacturers Inc. has expressed their commitment to consumer safety and is cooperating fully with the FDA to ensure all recalled products are removed from shelves and properly disposed of. The company is also working to ensure that future products comply with all FDA regulations before being marketed.

Background on Takata Air Bag Recall

The issues with the recalled infant formulas are reminiscent of other large-scale recalls, such as the Takata air bag recall, which highlighted the importance of strict regulatory compliance and consumer safety. The Takata recall involved over 100 million air bag inflators worldwide, underscoring the global impact and critical nature of adhering to safety standards.

Ongoing Monitoring

The FDA continues to monitor the situation closely and will provide updates as necessary. They encourage consumers to stay informed about recalls and to regularly check for updates on the FDA website.

Conclusion

The recall of Crecelac and Farmalac-branded infant formulas serves as a critical reminder of the importance of regulatory compliance and the rigorous evaluation required to ensure the safety and nutritional adequacy of products designed for infants. By taking immediate action to remove these products from circulation and advising consumers to consult with health care providers, Dairy Manufacturers Inc. and the FDA aim to protect the health and well-being of infants across the country.

For further information and updates, consumers can refer to the FDA website or contact Dairy Manufacturers Inc. directly.