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The US food and drug regulator has warned Reckitt and two other baby formula makers about their manufacturing safety standards after the three companies were forced to recall potentially contaminated baby formula.
In February, Reckitt, which also manufacturers Dettol disinfectant and Nurofen painkillers, recalled 145,000 cans of its ProSobee infant formula because of possible cross-contamination with a bacteria called Cronobacter sakazakii, which can cause sepsis and meningitis.
The US Food and Drug Administration also sent warning letters to ByHeart and Perrigo, two other manufacturers that recalled batches of formula because of the potential presence of the bacteria.
The FDA said in the letter to Reckitt it had found “significant violations” of quality control regulations at two of its manufacturing plants and that the assessments the company carried out following the contamination incidents were insufficient.
“Upon receiving notification of this result, you failed to conduct an independent root cause analysis or investigation and you did not evaluate whether other products may have been impacted by this contamination event,” the FDA wrote, referring to a discovery of the bacteria at one of the facilities.
At the time, Reckitt said the cause of the contamination was material from a third party and it was no longer sourcing this material from the supplier.
The FDA said the company recalls had been effective and had successfully removed the contaminated batches from the market.
Reckitt said it was still reviewing the FDA’s letter but added that its contents had raised no new concerns. “All of our infant formula products continue to meet the highest FDA standards . . . Infant formula safety is our top priority, and we are confident in the rigour of the programs we have in place to ensure the safety of every infant formula product we ship,” it said.
Perrigo said it was reviewing the letter and that it related only to a manufacturing facility it bought last year. ByHeart did not immediately respond to a request for comment.
Last year, Reckitt was considering a sale of its US infant nutrition business, Mead Johnson, following the disposal of its China business to private equity group Primavera for $2.2bn in 2021. Democratic lawmakers called for a probe of any potential sale of the US unit, warning it “could shallow out” the market after supply shortages during the pandemic.
The shortage was exacerbated by the closure of a baby formula factory belonging to Abbott Laboratories, the second-biggest US supplier, after reports of bacterial infections in babies. US supply has now recovered, according to the FDA.
Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said the regulator was “committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage”.
The Abbott closure helped boost profits at Reckitt, which is now the biggest provider in the US. Reckitt bought Mead Johnson in 2017 for $18bn, its largest ever acquisition.
Bruno Monteyne, analyst at Bernstein said investors considered the deal a failure. “[Reckitt] should definitely sell it, but it won’t get any easier to do so when you have the FDA concerns.”
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