Baby Formula Recall Issued Due to FDA Noncompliance
Key Takeaways
Dairy Manufacturers Inc. is recalling all lots of Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose formulas due to lack of FDA premarket notification.
The recalled formulas haven't been assessed by the FDA for safety or nutritional adequacy. Consumers are advised to stop using them.
No illnesses have been linked to the formulas, but caution is urged due to the lack of FDA evaluation.
FDA premarket notification ensures infant formula safety and proper nutrition for babies who rely on it.
Texas Baby Formula Recall: Products Lack FDA Evaluation
Texas-based company, Dairy Manufacturers Inc., is recalling all lots of three infant formula products due to noncompliance with U.S. Food and Drug Administration (FDA) requirements.
The announcement that was published by the FDA on Saturday applies to Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose formulas.
Why the Recall?
The recall stems from the company's failure to meet the FDA's premarket notification requirements for new infant formula. As per section 21 of the Code of Federal Regulations, manufacturers and distributors must register their infant formula products with the FDA before interstate commerce.
"This was identified after an FDA notification, because the firm has not submitted the required premarket notification," stated the official announcement.
The FDA has not evaluated the nutritional content or safety of the recalled formulas.
While no illnesses have been reported in connection with these products, the announcement emphasizes, "Parents and caregivers should understand that the products have not been evaluated by [the] FDA to determine whether they meet U.S. food safety and nutritional standards."
Products Affected
The baby formula recall products affected are packaged in 12.4-ounce cardboard and aluminum cans with expiration dates in August and September 2025. They were sold exclusively at retail stores within Texas.
Consumers who purchased Crecelac Infant 0-12, Farmalac 0-12, or Farmalac 0-12 Low Lactose are urged to discontinue use immediately and return them to the original point of purchase for a full refund.
Dairy Manufacturers Inc. assures consumers that no adverse reactions or illnesses have been linked to the recalled products. However, they advise contacting a healthcare provider if any health concerns arise related to consumption.
"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," the company stated in their announcement.
For further information or inquiries, consumers can contact Dairy Manufacturers Inc. at 1-972-347-2341, Monday through Friday, between 9:30 AM and 5:00 PM Eastern Time.
Importance of Infant Formula Recalls
Recalls of infant formula products are typically issued when there's potential consumer harm. This can involve contamination, mislabeling that omits allergens, or, as in this case, a lack of proper FDA evaluation for safety and nutritional adequacy.
This recent Texas recall follows another infant formula-related incident earlier this month. A Washington-based company recalled their Goat Milk Formula Recipe Kit due to insufficient nutritional content when used solely as an infant formula.