ByHeart Inc. has expanded a voluntary recall of its infant formula nationwide as federal investigators continue to examine a spike in infant botulism cases, the company said in a news release from the U.S. Food and Drug Administration (FDA).

The action affects all batches of ByHeart Whole Nutrition Infant Formula 24 oz cans and 0.6 oz Anywhere Pack packets. The recall includes Alabama, where the products are sold through national distribution channels.

The company said in the release that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, yet it broadened the recall as a precaution while the FDA and the Centers for Disease Control and Prevention review a surge of 84 infant botulism cases reported since August.

“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” Mia Funt, ByHeart co-founder and president, said in the release. “This nationwide recall reflects our commitment to protecting babies and giving families clear actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”

The FDA alerted ByHeart to the broader investigation on Nov. 7. The company said it is recalling all product from the market while federal officials work to identify a root cause of the outbreak. ByHeart also said it has begun sending every batch of formula to an independent laboratory for testing, has given FDA and California Department of Public Health teams unrestricted access to its facilities and unopened cans, and will publish test results from regulators and independent analysts as they become available.

The Alabama Department of Agriculture and Industries (ADAI) said their food safety inspectors are conducting recall effectiveness checks.

“ADAI is working closely with the Alabama Department of Public Health, CDC and FDA to be sure all remaining products are removed from store shelves,” said Agriculture and Industries Commissioner Rick Pate. “The health and safety of children is our top priority.”

After inspecting a total of 93 stores, ADAI food safety inspectors have collected 57 products from 10 separate locations.

The recall covers every batch of the affected formula. Product identifiers listed in the release include the ByHeart Whole Nutrition Infant Formula can UPC 85004496800 and the Anywhere Pack UPC 85004496802. Officials urged consumers to check packaging carefully to verify whether they purchased recalled items.

Infant botulism is a rare but serious illness caused when Clostridium botulinum spores colonize an infant’s intestinal tract. Symptoms can include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, breathing problems and possible respiratory arrest. Medical attention should be sought immediately if these signs appear.

Consumers should stop using and dispose of any ByHeart formula affected by the recall. Illnesses or adverse events can be reported through an FDA Consumer Complaint Coordinator, an electronic Voluntary MedWatch form or a paper MedWatch form mailed to the agency.

Parents with questions can reach ByHeart at hello@byheart.com or call (833) 429-4327. More information is available at www.byheart.com or on the FDA website at www.fda.gov.