ByHeart is recalling two lots of its organic powdered infant formula after federal officials linked it to a 10-state outbreak of infant botulism, which has hospitalized 13 children since August.

The recalled lots carry Dec. 1 “use by” dates (206VABP/251261P2 and 206VABP/251131P2), and parents are urged to discard any remaining product.

Cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

While ByHeart and government tests have not yet confirmed botulism in the formula, the company is voluntarily recalling the product as a precaution, NBC News has reported.

Infant botulism, caused by botulinum toxin, can lead to constipation, poor feeding, difficulty swallowing, and paralysis, but it can be treated with BabyBIG, an FDA-approved therapy.