Enfamil, Gerber, ByHeart Manufacturers Receive FDA Warning Letters Over Infant Formula Cronobacter Contamination

Officials are requiring several infant formula manufacturers to sanitize their production plants after identifying cronobacter contamination that could pose serious health risks to infants.

Following last year’s infant formula shortage triggered by a massive Similac cronobacter recall, which seriously sickened infants nationwide, federal health officials are investigating similar bacterial contamination problems found at three infant formula manufacturing plants responsible for the production of Enfamil, Gerber and ByHeart products.

The U.S. Food and Drug Administration (FDA) issued warning letters to Mead Johnson Nutrition (Reckitt), ByHeart Inc. and Perrigo Wisconsin, LLC on August 30, stating that routine facility inspections found evidence of cronobacter in critical hygiene zones of the infant formula manufacturers’ production plants, along with other violations.

Cronobacter sakazakii is a rare type of bacteria, often found in dry foods, such as infant formula, skimmed milk powder, tea and starches. The bacteria exists in the environment and can survive in very dry conditions, making transmission of the infection possible by touching contaminated surfaces.

The infections can be particularly deadly for infants and the elderly, or those with weakened immune systems. The bacteria may cause serious life-threatening infections or meningitis (an inflammation of the membranes that protect the brain and spine).

Infant Formula Cronobacter Recalls

In the new warnings about problems at the infant formula manufacturing plants, the FDA indicates that inspections conducted in recent months have identified several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the FDA’s Infant Formula regulations.

At the time these violations were observed, the agency quickly worked with each of the manufacturers to issue a series of infant formula cronobacter recalls, incuding a Gerber Good Start SoothePro recall in March 2023, an Enfamil ProSobee recall in February 2023, and a ByHeart Infant Formula Milk Based Powder recall in December 2022.

While the agency states that the new warning letters are not tied to any current infant formula recall request, the manufacturers are now being instructed to take immediate corrective actions to address the underlying risk, which will be subject to FDA approval.

Baby Formula Manufacturers Forced To Correct Contamination Hazards

According to the letters, the FDA is requiring the manufacturers to conduct root cause investigations, to determine how cronobacter bacteria was able to contaminate their facility.

The companies will be required to perform subsequent cleaning and sanitation activities and must properly reevaluate their cleaning and sanitation practices, schedules, and procedures before releasing infant formula products.

Each manufacturer will have 15 working days to respond to the FDA detailing the corrective actions being taken, which will be subject to an FDA assessment for adequacy.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is 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,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition.

Similac Lawsuits Over Infant Formula Contamination

In one of the largest infant formula recalls issued in recent years, Abbott Laboratories issued a Similac formula recall in February 2022, after disclosing the powdered infant formula manufactured at a Michigan facility was contaminated with Cronobacter sakazakii and Salmonella Newport bacteria.

Within days, reports began to surface that suggested the company knew about the Similac contamination problems at its facility since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infant infected with Cronobacter. In the months following the recall, at least two infant deaths and hundreds of illnesses were reported by parents who fed the contaminated baby formula to their children.

Subsequent investigations have revealed that Abbott ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits, leading to individual and class action lawsuits filed throughout the federal court system.

Abbott now faces dozens of Similac recall lawsuits brought by families of infants nationwide who were diagnosed with Salmonella, Cronobacter or other infections linked to bacteria at the manufacturing facility, and serious questions are being raised about why the problems were not addressed much earlier.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


September 2023 Infant Formula Lawsuit Update

Given common questions of fact and law raised in complaints filed against Abbott over the Similac recall, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois, who is working with the parties to select a small group of bellwether cases for early trial dates.

Each party will select five Similac recall cases to go through initial bellwether discovery, with each side selecting at least one claim involving a cronobacter diagnosis, one involving a meningitis diagnosis, and at least two which must involve Salmonella diagnoses without also involving a meningitis diagnosis, and a fifth case which can allege any specific type of diagnosis. These cases will be representative of the larger body of lawsuits pending in the federal court system, and the outcome of these early trial dates will be used to gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation.

In addition to lawsuits over the Similac cronobacter recall, Abbott Laboratories also faces a separate group of infant formula lawsuits involving premature babies diagnosed with a devastating intestinal condition after using cow’s milk-based products, known as necrotizing enterocolitis (NEC). Similar allegations have also been raised in a number of Enfamil lawsuits brought against Mead Johnson, who received one of the FDA warning letters this week.


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