FDA warns 3 baby formula makers over cleaning and sanitization

The FDA sent warning letters to three baby formula manufacturers regarding their cleaning and sanitizing practices. Each of the companies recalled products in the last year, and the FDA wants to ensure they’re taking steps to prevent it from happening again. 

The companies — Reckitt, Perrigo and ByHeart — make Enfamil Prosobee Simply Plant-Based Infant Formula, Gerber Good Start Soothe Pro and ByHeart Whole Nutrition Infant Formula, respectively. 

Each of those products were recalled in the last year due to possible contamination with Cronobacter sakazakii, a nasty germ that can lead to deadly infections. Although it’s rare, Cronobacter can cause sepsis and meningitis.  

After inspecting the companies’ facilities, the FDA found “significant violations” of federal regulations regarding good manufacturing practice, quality control procedures and more. The companies have 15 days to respond with a list of corrective actions.

To be clear — this does not have anything to do with an ongoing recall, and the FDA explicitly stated it is not advising discarding or avoiding the purchase of any product. 

“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,” Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement. 

Prater was referring to the February 2022 recall of Abbott products Similac, Alimentum or EleCare powdered infant formulas made at the company’s facility in Sturgis, Michigan. That caused a nationwide shortage of formula which led the Biden administration to fly it in from overseas. The investigation and recall began after infants became ill, leading to four hospitalizations and two deaths that may have been linked to Cronobacter. 

There are ways to ensure formula is safe at home. The FDA said the safest option for babies that are immuno-compromised or less than two months old is ready-to-feed liquid formula because it’s made sterile. 

But if powdered formula is the only option, the FDA suggests heating the water to 158 degrees fahrenheit and mixing the powder in to protect against cronobacter. Let it cool to body temperature, or about 98 degrees, before feeding. 

Some products, however, lose vitamins and nutrients if they are heated above 100 degrees, so check the manufacturer’s instructions.