FDA: Recall expanded for infant's liquid ibuprofen sold at Walmart, CVS and Family Dollar

In December, Tris Pharma, Inc. voluntarily recalled three brands of liquid ibuprofen for infants. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

The newest additions to the recall include medicine sold at CVS and Walmart:

(Sold at CVS with expiration date of 12/19)

(Sold at Walmart with expiration date of 12/19)

(Sold at CVS with expiration date of 12/19)

The recall issued in December still applies to these medicines sold at Walmart, CVS and Family Dollars nationwide:

(Sold at Walmart with expiration dates of 02/19, 04/19 and 08/19)

{Sold at CVS with expiration date 08/19)

(Sold at Family Dolalr with expiration date 08/19)

Some of the above medicines have Ibuprofen as high as 10 percent above the specified limit, according to the FDA. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose.

Wholesalers and retailers of the product should stop further distribution of the affected lots. Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 or via email at Customer Service Email. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.

Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.