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ByHeart has expanded its nationwide recall after new lab tests showed that its infant formula may be widely contaminated with bacteria that can cause botulism, a rare but dangerous illness in babies.

The company said the latest results raised serious concerns and urged parents to stop using the formula immediately.

In an update posted on its website, ByHeart explained that five of 36 tested samples from three different lots contained "Clostridium botulinum" type A, the bacteria linked to the ongoing outbreak, AP News reported.

Because the bacteria can be unevenly spread in powdered formula, the company said it cannot guarantee the safety of any product it has sold.

"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," the company wrote.

So far, at least 31 babies across 15 states have been sickened since August after drinking the formula, according to federal and state health officials.

Several infants who fell ill as early as late 2024 were also treated for botulism, though they are not counted in the current outbreak.

Health experts say all babies under 1 year old are at risk if they ingest the bacteria.

FDA Finds Recalled ByHeart Cans Still in Stores

Botulism in infants happens when spores grow in the intestines and produce a toxin.

According to CBS News, symptoms can take up to a month to appear and include trouble feeding, constipation, droopy eyelids, weak muscles, and a flat or tired facial expression.

Doctors stress that the illness is a medical emergency and needs quick treatment.

Since August, at least 107 babies nationwide have been treated with BabyBIG, the IV medicine used to fight infant botulism.

The recall was first announced on November 11, but officials from both the FDA and several states say some recalled cans were still found on store shelves afterward.

Parents are being told to check their formula right away, stop using it, and watch their babies closely for symptoms.

ByHeart said it is working to find the cause of the contamination and is reviewing every part of its production chain, from ingredients to packaging.

The company also announced that any product bought on its website on or after August 1 is eligible for a full refund, expanding its earlier refund policy.

Families who believe their child became sick after using the formula can report cases to the FDA through a consumer complaint coordinator or by submitting a MedWatch report online.

Several parents have already filed lawsuits accusing the company of selling unsafe formula and seeking help with medical bills and emotional distress.