Organic infant formula maker Byheart recalled all of its products sold in the United States on Tuesday, days after some lots were recalled due to an outbreak of infant botulism.
At least 15 infants in 12 states have become ill in the outbreak since August, and more cases are on the way, state and federal health officials say. All of the infants were hospitalized after ingesting Bihart formula, officials said. No deaths were reported.
Byheart officials have expanded the voluntary recall from the two lots announced on Saturday to all products in consumers' homes and stores. This includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of infant formula. The company sells about 200,000 cans of infant formula a month online and in stores including Target, Walmart, Albertsons and Whole Foods, said Chief Medical Officer Dr. Devon Kuehn.
Parents and caregivers who keep this formula at home “should immediately stop using it and discard the product,” Kuehn said.
Company officials said they carried out the unusual recall “in close coordination” with the U.S. Food and Drug Administration, even though the unopened product did not test positive for contamination. According to company officials, the types of bacteria that produce this toxin are widespread in the environment and may come from sources other than the drug combination.
“This action underscores Byheart's core mission of protecting babies above all else,” the company said in a statement.
California health officials previously confirmed that samples from an opened can of Bihart formula given to sick infants contained a type of bacteria that produces toxins.
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The U.S. Food and Drug Administration recommended that Byhart expand its recall due to the number of sick infants reported to have ingested the formula, the identification of additional lot codes, the increasing number of cases, and the results of a California test.
The FDA is investigating 84 cases of infant botulism detected since August. Fifteen of them took ByHeart formula, authorities said in a statement.
“This information indicates that ByHeart-branded formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart accounts for an estimated 1% of all infant formula sales in the United States,” the FDA statement said.
The infections began between August 9 and November 10, federal officials said. Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Investigators have not identified other brands of infant formula or other sources of exposure in the outbreak, officials said.
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Kuehn said Byhart manufactures the powdered milk at a factory in Allerton, Iowa, and transports it to a site in Portland, Oregon, for canning and distribution. U.S. Food and Drug Administration inspectors were at the Portland plant on Monday, she added.
In addition to the broader recall, the company said it will test every batch of baby formula at an independent third-party laboratory, provide health authorities with full access to the company's site, and share results with regulators as they become available.
Infant botulism is a rare and serious disease that occurs in infants less than one year of age whose intestinal microbiota is immature. It is caused when an infant ingests bacteria that contain toxin-producing spores in the intestines. Symptoms include constipation, poor feeding, droopy eyelids, decreased muscle tone, difficulty swallowing, and difficulty breathing.
Babies who develop these symptoms require immediate medical attention. The only treatment for this infection is BabyBIG, an intravenous drug made from the plasma of people vaccinated against botulism.
It is unclear whether the U.S. recall applies to Canadian consumers of the same Byheart infant formula, or whether there have been any reported cases of infant botulism associated with use of the product in Canada.
Global News reached out to Health Canada for further information, but had not received a response at the time of publication.
– With files from Global’s Ari Rabinovitch
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