Another Infant Formula Recall Due to FDA Non-Compliance. Dairy Manufacturer, Inc. Recalls Three Products.

Another infant formula recall due to US. Food and Drug Administration (FDA) non-compliance has been issued. This is the second this month for this category. However, several other infant formula recalls are still listed as active according to the FDA’s “Recalls, Market Withdrawals, & Safety Alerts” website.

Dairy Manufacturers, Inc, of Prosper, Texas announced a voluntary recall on May 24, 2024 for three products. The safety of these products cannot be guaranteed, because they have not been evaluated by the FDA.

Dairy Manufacturers Inc. Issues Voluntary Infant Formula Recall

Dairy Manufacturers, Inc. issued a recall on their Crecelac and Farmalac infant formula products because they had “not been evaluated by [the] FDA to determine if they meet U.S. food safety and nutritional standards” for infant formula.

Recalled product includes:

• Crecelac Infant 0-12
  • UPC: 8 50042 40847 6, Exp Date: 08/2025
  • UPC: 8 50042 40847 6 ,Exp date: 09/2025
• Farmalac 0-12
  • UPC: 8 50042 40841 4, Exp Date: 08/2025
  • UPC: 8 50042 40841 4, Exp Date: 09/2025
• Farmalac 0-12 Low Lactose
  • UPC: 8 50042 40839 1, Exp Date: 08/2025
  • UPC: 8 50042 40839 1, Exp Date: 09/2025

Product can be identified as packaged in a cardboard and aluminum can weighing 12.4 oz. Products were sold at retail stores only in the state of Texas.

There have been no reports of illness or adverse effects associated with this recalled Crecelac and Farmalac formula products to date.

Why Is This Such a Big Deal?

You may be wondering why this recall is such a big deal. No babies have become sick so far. Why does the FDA have these rules?

Infant formula is highly regulated in the United States. This product is meant for the youngest and most vulnerable of the country’s members. It is also potentially the only source of nutrition for many infants.

Because of this, products labeled as “infant formula” must meet certain nutritional and safety standards.

The first step in the process is to submit a premarket notification to the FDA. Dairy Manufacturers, Inc. did not do this. While the rest of the criteria may have been met, all infant formula sold in the United States (including imported products) must be evaluated by the FDA. Consequently, Dairy Manufacturers, Inc. was encouraged to issue the infant formula recall voluntarily. And so they did.

What Does the FDA Evaluate for in Infant Formula Products?

There are several criteria that the FDA evaluates in infant formula products. Namely, product labeling, appropriate sanitation controls at the facility, and most importantly – nutritional requirements.

Evaluated Labeling Requirements

For a product to be sold as an infant formula in the United States, certain labeling aspects must be present.

First, the packaging should include clear directions for product preparation and use. Additionally, pictograms depicting major steps are also necessary to ensure instructions are more easily understood. Also, the label must include a “use-by” date.

Evaluated Sanitation Controls Requirements

Certain aspects, such as facility controls and ingredient selection are also evaluated as sanitation controls for infant products intended for sale in the United States.

All ingredients used in infant formula must be “safe and suitable for such use” and certain facility controls to ensure safety must be considered. Additionally, water used by an infant formula manufacturer must meet certain safety standards set by the U.S. Environmental Protection Agency (EPA).

Facilities must be inspected annually.

Evaluated Nutritional Requirements

The FDA specifies that 30 nutrients must be included in infant formulas as well as the minimum amounts of each. This ensures that it meets the entire nutritional needs for a newborn if the formula is the only source of food.

For some ingredients, a maximum level is indicated. While important in certain concentrations, sometimes an ingredient can cause an overdose. For this reason, 10 of those ingredients have an established maximum level.

This is Not the Only Active Formula Recall

Unfortunately, several infant formula recalls are still listed as active status. Meaning that they may still be in circulation or in consumers’ homes. Some are recalled for the same reason as Dairy Manufacturer, Inc., because they have not been evaluated by the FDA. Others are recalled for safety concerns.

Mt. Capra Goat Milk Formula Recipe Kit Recalled Due to Concerns About Insufficient Nutrition

Mt. Capra Goat Milk Formula Recipe kits were recalled earlier this month after concerns of insufficient nutrition. This was brought to the FDA’s attention after a report of infant anemia was traced back to the product.

Recalled product were sold in 10-pound, 2-ounce packages online and in a single retail store in Chehalis Washington between May 1, 2023, and May 1, 2024.

Sammy’s Milk Goat Milk Toddler Formula Recalled Due to Concerns About Insufficient Nutrition

Sammy’s Milk recalled their Goat Milk Toddler formula in April due to concerns that it did not provide “sufficient nutrition when used as an infant formula.” While the product is labeled as a “toddler formula,” the wording on the website was ambiguous at its use as an infant formula.

Recalled product was sold online with a lot code of SD348 and a “best by” date of August 2025.

Reckitt/Mead Johnson Nutrion Nutramigen Powder Recalled Due to Potential Cronobacter Contamination.

Reckitt/Mead Johnson Nutrition recalled two products last December due to potential contamination with the harmful bacteria, Cronobacter sakazakii.

Recalled products included 12.6-ounce and 19.8-ounce packages with UPC codes 300871239418 and 300871239456. These products have a “use-by” date of January 1, 2025.

Perrigo Company Plc Gerber Good Start Product Recalled Due to Potential Cronobacter Contamination.

Perrigo Company Plc recalled select packages of Gerber Good Start SoothProTM Powdered Infant Formula in March 2023 due to potential contamination with the harmful bacteria, Cronobacter sakazakii.

Recalled products include 12.4-ounce packages with expiration dates from July 4 to July 12, 2024, 19.4-ounce packages with expiration date July 16, 2024. and 30.6-ounce packages with expiration dates of July 14 to July 16.

Have You Purchased Product Included in an Infant Formula Recall and Experienced Negative Effects in Your Child?

If you have purchased a recalled infant formula product and your child experienced negative effects as a result, it is a good idea to consult with an Infant Formula lawyer. The Lange Law Firm is here to help.

Call (833) 330-3663 or click here for a free consultation. A member of our compassionate team can help go over the details of your case.

By: Heather Van Tassell (contributing writer, non-lawyer)