Tris Pharma Inc. is voluntarily recalling three lots of infants’ ibuprofen sold at Walmart, CVS and Family Dollar, due to the discovery that the product potentially has higher concentrations of ibuprofen, according to the U.S. Food and Drug Administration.
The FDA said there is a remote possibility that infants, who are more susceptible to a higher potency level of the drug, would be more vulnerable to permanent NSAID-associated renal injury. Adverse effects include nausea, vomiting, epigastric pain and, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects, according to the FDA.
To date, the company has not received any reports of adverse effects related to its products.
The products included in the recall, packaged in 0.5-ounce bottles are:
- Equate: Infants’ Ibuprofen Concentrated Oral Suspension UPS (NSAID), sold at Walmart
- CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension UPS (NSAID), sold at CVS Pharmacy
- Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID), sold at Family Dollar Services Inc.
Consumers with questions can contact Tris Customer Service at 732-940-0358.