Tris Pharma Inc. is recalling approximately 204,528 bottles of Infants' Ibuprofen Concentrated Oral Suspension (50 mg per 1.25 mL) sold under the Walmart, CVS, and Family Dollar brands. These bottles may contain a higher concentration of ibuprofen than labeled, which can lead to accidental overdosing in infants. The affected products were distributed nationwide in the United States and were sold in 0.5 FL OZ (15 mL) bottles with berry flavors. Consumers who have purchased these products should immediately stop using them and contact their healthcare provider or pharmacist.
The recalled medication is 'superpotent,' meaning it contains more ibuprofen than specified on the label. Infants are particularly susceptible to ibuprofen toxicity, and an accidental overdose can cause permanent kidney injury, nausea, vomiting, epigastric pain, or more rarely, diarrhea, tinnitus, headache, and gastrointestinal bleeding.
Full refund at place of purchase
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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