The Food and Drug Administration is expanding its advisory on powdered baby formulas to include a certain lot of specialty Similac PM 60/40.
Abbott Nutrition voluntarily recalled the specialty product on Monday after learning that an infant who consumed the Similac specialty product died after testing positive for Cronobacter sakazakii. It was the second reported fatal case linked to powdered baby formula since September.
In an update to an advisory released less than two weeks ago, the FDA cautioned against using Similac PM 60/40 with lot code 27032K800 on the case and 27032K80 on the can. The product is intended for infants who need a lower mineral intake.
The case remains under investigation and the cause of the infant's infection has not been determined, according to Abbott's website.
"Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release," Vicky Assardo, senior director of global public affairs for Abbott Nutrition, told NPR in a statement. "All infant formula products are tested for Cronobacter sakazakii and other pathogens and they must test negative before any product is released."
A Michigan plant was the focus of an earlier recall
On Feb. 17, Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, voluntarily recalled certain formulas manufactured at its plant in Sturgis, Mich.
You can check whether the initial recall affected your powdered formula by inspecting the code printed near the expiration date. Affected products have a code beginning with the first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later.
Cronobacter infections are rare but can be especially dangerous for newborn babies. Symptoms include poor feeding, jaundice and grunting breaths, according to the FDA. Those infected with salmonella might experience fever, diarrhea and abdominal cramps.
Frank Yiannas, FDA deputy commissioner for food policy and response, said the administration is working with partners to investigate complaints about formula produced at the Sturgis facility.
"As this is a product used as the sole source of nutrition for many of our nation's newborns and infants, the FDA is deeply concerned about these reports of bacterial infections," the agency said in a release.
Parents of a sickened infant file a class-action lawsuit against Abbott
Since the initial recall, a Florida law firm filed a nationwide and statewide class-action lawsuit against Abbott Laboratories, the company's parent. Plaintiffs allege Abbott put children at risk of injury and infection.
The suit was filed by Schlesinger Law Offices on behalf of two Miami parents and their infant daughter, who was infected with salmonella after consuming Alimentum. Their child developed severe illness, which the lawsuit says was a "direct result" of consuming the formula. The child continues to experience gastrointestinal and bowel problems, the law firm said in a release last week.
According to the lawsuit, the parents purchased Alimentum for their daughter in October 2021. At least one of the products they bought matched the ones identified in the FDA's advisory in February.
"Abbott's failure to use reasonable care regarding these infant formula products - and then failing to warn the public after recognizing that a problem within their facility existed is reckless and dangerous," Jonathan Gdanski of Schlesinger Law Offices said in a release.
The company has received the complaint and is reviewing it, Assardo told NPR in a statement. Safety and quality are the company's "top priority," Assardo added.
"As part of Abbott's quality processes, all infant formula products are tested for Cronobacter sakazakii, Salmonella and other pathogens, and they must test negative before any product is released," Assardo told NPR. "No distributed product from our Sturgis, Mich., facility has tested positive for the presence of either Cronobacter sakazakii or Salmonella."