Creselac and Pharmalac brand infant formulas are being recalled because they were put on store shelves without being properly evaluated by the Food and Drug Administration (FDA).
Dairy Manufacturers Inc. has voluntarily recalled all lot codes of infant formula sold in the U.S. at the retail and wholesale levels, including Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose.
According to a notice issued by the FDA, the products were “sold in the United States without complying with FDA’s infant formula regulations.”
The FDA has notified the dairy manufacturer after it discovered that the manufacturer had not submitted a required premarket notification.
“Parents and guardians should be aware that these products have not been evaluated by the FDA for whether they meet U.S. food safety and nutrition standards,” the recall notice states.
The affected products were labeled as infant formula and were packaged in 12.4-ounce cardboard and aluminum cans.
The products were sold at retailers in Texas, though the notice did not specify which stores.
No known injuries or side effects have been reported, but the recall warning says consumers are “strongly urged to stop using the recalled products and return them to their place of purchase for a full refund.”
The notice urges concerned consumers to contact their health care provider.
“We deeply apologize for any inconvenience or concern this may have caused, and we assure our customers that we are taking all necessary measures to ensure the safety, quality and compliance of our products,” the company said.
