The U.S. Food and Drug Administration has sent letters to three baby formula companies expressing concerns about quality control issues at some of their facilities, the agency said in a statement Wednesday.
The letters went to manufacturers Reckitt/Mead Johnson, Perrigo and ByHeart after the FDA found the companies failed to ensure their infant formula was not contaminated during the manufacturing process.
The FDA conducted inspections following infant formula recalls by all three companies last year, however, there are no recalls of products at this time, the agency said
At the time of each inspection, the FDA “issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace,” according to the agency.
[ Recall alert: Baby formula that had been recalled sent out to stores in 8 states ]
“You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” the letters sent Wednesday read.
A spokesperson for Perrigo told NBC’s “Today” that the company has “been committed to meeting the needs of consumers, parents and caregivers — and the quality and safety of our products is our highest priority,” adding that the letter Perrigo received “pertained only to its infant formula manufacturing facility located in Wisconsin, which Perrigo acquired from Nestle on November 1, 2022.”
“As noted in the FDA’s press release, we want to assure the public that all of Perrigo’s infant formula products available to parents and caregivers are safe for infant feeding, and FDA does not advise discarding or avoiding purchase of any particular infant formula,” the spokesperson added.
A spokesperson for Reckitt and Mead Johnson Nutrition told “Today” that “the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality.
“The FDA’s communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections,” the spokesperson continued, adding that to date there “are no safety or quality concerns with any Reckitt/Mead Johnson formula.”
A ByHeart company spokesman told ABC News‚ “We commend the FDA for its efforts to unify the industry’s ongoing work to elevate manufacturing standards and support the Agency’s enhanced oversight.
“Providing safe and high-quality infant formula continues to be our top priority and we can assure our customers that no distributed ByHeart product has tested positive for contaminants. There is no disruption to ByHeart’s manufacturing and we currently have three production plants across the U.S. that are operating to meet the demand for our formula.”
The three manufacturers produce the brands Enfamil, ByHeart, Parent’s Choice and store brand formulas, including Walmart, Sam’s Club, Costco and Target.