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Baby formula maker issues urgent recall after failing to register ingredients with FDA
A Texas baby formula manufacturer has issued an urgent recall after failing to register ingredients with the Food and Drug Administration.
Prosper-based Dairy Manufacturers, Inc. announced on May 24 that it was conducting a voluntary recall after failing to comply with FDA regulations.
The company recalled all lot codes for Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low Lactose at both the retail and wholesale levels.
The affected products are packaged in 12.4-ounce cans and have expiration dates of August 2025 and September 2025. According to the FDA, the formula retailed exclusively in the state of Texas.
The products were found in non-compliance with the agency's requirements for the registration of new infant formula.
Dairy Manufacturers, Inc. has issued a recall for Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low Lactose infant formula (file photo)
The Prosper, Texas-based company (pictured) was found in non-compliance with the Food and Drug Administration's rules for registration of new baby formula
While no adverse reactions have been reported to date, the products nonetheless pose a risk, as their ingredients have yet to be evaluated to determine whether they meet food safety and nutritional standards.
In the event that an illness does occur, consumers are urged to contact a healthcare provider.
Those who purchased any of the recalled products are encouraged to discontinue use and return them for a full refund.
'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 said in a statement.
The FDA has been bringing the hammer down on manufacturers in the wake of the February 2022 recall of several brands of Abbott's powder infant formula.
The recall came in response to the death of an infant who tested positive for Cronobacter sakazakii, a bacterium that causes bloodstream and central nervous system infections.
The affected products are packaged in 12.4-ounce cans and have expiration dates of August 2025 and September 2025
The formula retailed exclusively in the state of Texas and was recalled at both the retail and wholesale levels
While no illnesses have been reported to date, the ingredients have not been evaluated against the FDA's food safety and nutritional standards
While none of the recalled product had tested positive for the presence of Cronobacter or Salmonella Newport, an animal-transmitted bacterium, four children had fallen ill after consuming Similac PM 60/40. This included a second infant who died.
Testing in the company's Sturgis, Michigan, facility found Cronobacter contamination in non-product contact areas.
The FDA later announced that an analysis did not samples from patients to be closely genetically related to the strains found in the factory.
Abbott ultimately resumed production at its Sturgis facility amid a nationwide formula shortage.
'Making infant formula is a responsibility we take very seriously, and parents can feel confident in the quality and safety of Similac and other Abbott formulas. We are committed to re-earning the trust parents and healthcare providers have placed in us for decades,' CEO Robert B. Ford said in a statement.
The FDA continues to conduct routine inspections of facilities used to produce baby formula.
The agency also updated its strategy to prevent Cronobacter illnesses associated with the consumption of powdered formula.