Handout image of recalled ByHeart Whole Nutrition Infant Formula.

A voluntary recall linked to over a dozen cases of infant botulism has now expanded.

In a news release on Tuesday, Nov. 11, ByHeart Whole Nutrition Infant Formula announced that it is expanding its recall to include all batches of its ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs.

As of Monday, Nov. 10, the FDA's update on their website states that there have now been "a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula". When the recall was initially reported, it was 13 cases.

"The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority," Mia Funt, ByHeart's co‑founder and president, said in the news release. "This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information."

Here's what to know about the recall.

When was the baby formula recall first announced?

The U.S. Food and Drug Administration first announced the voluntary recall of certain batches of ByHeart's infant formula on Nov. 8.

Baby formula recall: See the states with reported cases of infant botulism

  • Arizona
  • California
  • Kentucky
  • Illinois
  • Minnesota
  • New Jersey
  • North Carolina
  • Oregon
  • Pennsylvania
  • Rhode Island
  • Texas
  • Washington

It was initially 10 states, but that has now broadened to 12. New states include Kentucky and North Carolina. The states reporting the most cases are California, Illinois and Texas, according to the Centers for Disease Control and Prevention. They each have two cases apiece. The rest only have one reported case.

What baby formula products are being recalled?

ByHeart has voluntarily recalled all batches of its ByHeart Whole Nutrition Infant Formula cans and all Anywhere Packs.

Where was the recalled baby formula sold?

The recalled products were sold online and in major retailers nationwide, according to the FDA.

Have there been any hospitalizations or deaths related to the baby formula recall?

A total of 15 cases of infant botulism were reported, according to the CDC. Each case resulted in a hospitalization.

According to the most recent update on the FDA's website, no deaths have been linked to the outbreak.

'Too many unanswered questions': Investigation into infant botulism cases continues, company says

The FDA and CDC are also investigating 84 cases of infant botulism that spiked in August, according to ByHeart. The company says it is also doing its own investigation.

A letter shared to ByHeart's website and social media pages from the co-owners Mia Funt & Ron Belldegrun reads in part, "The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority."

What are the symptoms of infant botulism?

Parents and guardians who see the following symptoms in an infant should seek immediate medical care, according to the CDC:

  • Poor feeding
  • Loss of head control
  • Difficulty swallowing
  • Decreased facial expression

Parents and guardians who have recently fed their infant the recalled formula should remain vigilant, as botulism can take multiple weeks to develop.

Infant botulism can be fatal and should be taken care of immediately.

What to do if you purchased the recalled formula

Parents who purchased the recalled formula should stop using it immediately and either throw it away or return it to the store where it was purchased.

This story has been updated to add new information.

Contributing: James Powel, USA TODAY

Julia is a Trending reporter for USA TODAY and covers scientific studies and trending news. Connect with her on LinkedIn, X, Instagram, and TikTok: @juliamariegz, or email her at jgomez@gannett.com

This article originally appeared on USA TODAY: ByHeart baby formula recall tied to botulism risk now includes all products

Reporting by Julia Gomez, USA TODAY / USA TODAY

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