Infant ibuprofen recall expanded to include 3 additional lots sold under CVS and Walmart brands

Tris PharmaAn image of one of the medicines being recalled, from Tris Pharma.
  • Tris Pharma is expanding a recall of batches of liquid ibuprofen sold for infants, because the medicines may have a higher concentration of the drug, which could harm babies.
  • The products were sold under CVS Health, Walmart, and Family Dollar brands.
  • Information on the expanded recall is available online from the US Food and Drug Administration.

A recall of liquid ibuprofen for infants is being expanded to include additional batches of the medication, Tris Pharma announced on Tuesday.

In a press statement, Tris Pharma said it would be pulling some of its ibuprofen oral suspensions sold under brands from CVS Health, Walmart, and Family Dollar, as the products may have a higher concentration of ibuprofen, which could harm infants.

The company also said that “no serious adverse events have been reported related to this recall.”

More information on the expanded recall, including which specific lots are affected, is available in a statement from the company.

During the initial recall in December, Peter Ciano, Tris Pharma’s acting chief financial officer, told Business Insider that the concentration of ibuprofen in the products was about 10% higher than it should be. That means the chance of harm is pretty low, he said.

“The margin of safety on a product like this is pretty high,” Ciano said in an interview. “The fact that it’s 10% isn’t appropriate, so we called it back, but in all likelihood, it doesn’t present a safety issue.”

Ibuprofen is used to relieve pain or treat fevers. If infants are exposed to doses of the product that are too high, their kidneys could be permanently injured, Tris Pharma said. Side effects to watch for include nausea, vomiting, stomach pain, and diarrhoea.

(This article was initially published in December and has been updated).

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