Tris Pharma Inc. is recalling approximately 116,688 bottles of Infants' Ibuprofen Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL. The recalled medications, sold under brand names at CVS Pharmacy and Walmart, may contain a higher concentration of ibuprofen than what is stated on the label. This superpotent formulation means infants could inadvertently receive a much higher dose than intended, which could lead to serious health complications.
There is a remote possibility that infants, who may be more susceptible to a higher dose of ibuprofen, may be more vulnerable to permanent NSAID-associated renal injury. Other adverse health effects include nausea, vomiting, epigastric pain, or more rarely, diarrhea, tinnitus, headache, and gastrointestinal bleeding.
Refund and guidance
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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