Did FDA bungle infant formula recall?

Safety inspectors knew of problems at facility months before recall

Abbott Nutrition’s manufacturing plant that produced baby formula had a history of safety regulation violations, but it stayed open, a Consumer Reports investigation found. It wasn’t until after a baby died that the company issued a recall. Now, there are questions about whether the FDA could have acted sooner.

If you’re a parent shopping for baby formula, you might notice sparsely stocked store shelves or limits on how much you can buy.

“Formula right now is hard to find because of recalls by Abbott nutrition of its Similac, Alimentum, and Elecare powdered infant formula,” said Consumer Reports’ Ryan Felton.

The recalls come after at least two infant deaths and several illnesses potentially tied to formula. The cases involved extremely dangerous bacteria called cronobacter sakazakii and salmonella Newport.

“Cronobacter bacteria is extremely deadly with a mortality rate as high as 80 percent in infants,” Felton said.

The Consumer Reports investigation found that the Food and Drug Administration knew about problems at the Abbott plant in Michigan back in September.

“The FDA didn’t warn consumers about Abbott’s infant formula until it conducted a follow-up inspection last month. And we still don’t know why,” Felton said.

Last week, the FDA said it found a history of cronobacter contamination at the plant dating back to 2019.

The FDA has declined to answer questions from Consumer Reports about what it knew when it visited the plant in September.

Now, there are serious questions being raised by members of Congress about the agency’s ability to regulate the infant formula marketplace.

“I think what’s especially disturbing is that the FDA hasn’t been forthcoming. So ultimately, it’s not surprising that it would get the attention of a key lawmaker in congress who would try and set up some sort of investigation to scrutinize the agency’s actions,” Consumer Reports’ Brian Ronholm said.

After the latest recall, Abbott said, “this case is under investigation, and at this time, the cause of the infant’s cronobacter sakazakii infection has not been determined.”

Abbott has not made a full list of recalled products available to the public. Consumers will need to use a lookup tool on the company’s website to find out if they have a product that is part of the recall.

Parents who purchase affected formula with SNAP benefits can temporarily buy other brands not usually covered by the program. Check with WIC or the retailer for exchanges or which brands can be purchased.


FDA: Do not use recalled infant formulas tied to infections

About the Author:

As a consumer reporter, Marilyn is all about helping people stay safe and save a buck. Since coming to KSAT in 1985, she’s covered everything from crime to politics, winning awards for her coverage of the Mexican Mafia, Oklahoma tornadoes, children’s transplants, an investigation into voting irregularities and even a hit-and-run Santa Claus.