The U.S. Food and Drug Administration recently expanded its infant ibuprofen recall. Tris Pharma issued a voluntary recall of its Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL initially in December 2018. Representatives from Tris Pharma referred to its statement online about the recall when reached for comment.
The recall expansion, announced Jan. 30, 2019, includes three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL. The infant ibuprofen, sold by CVS, Family Dollar and Walmart, may contain up to 700 percent higher concentrations of ibuprofen than the recommended dose, posing a serious health risk. Potential adverse effects from taking this over-the-counter medication could include vomiting, nausea, diarrhea, abdominal pain, headache or ringing in the ears.
Recalled Infants’ Ibuprofen Description
The current recall includes three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, packaged in 0.5 oz. bottles. Again, the affected products were sold at CVS, Family Dollar and Walmart stores. Visit the FDA’s website for a full list of the initially and currently recalled products, lot numbers and expiration dates here.
The brand names that the ibuprofen was sold under include Equate (at Walmart stores), CVS Health (at CVS) and Family Wellness (at Dollar General). You can also see the label and packaging scans below.
Photos: PRNewsfoto/Tris Pharma, Inc.
Why the Ibuprofen Was Recalled
The ibuprofen oral suspension may contain concentrations of the medication that are dangerous to infants. Along with GI symptoms, such as vomiting, diarrhea, abdominal pain and gastrointestinal bleeding, the potentially dangerous concentration of ibuprofen may also cause headaches and ringing in the ears.
It’s also possible that infants who are more susceptible to the higher potency may experience permanent NSAID-associated renal injury. Currently, no illnesses or injuries have been reported.
How To Tell If Your Ibuprofen Is Part of the Recall
Review the lot number, expiration date, description and seller name at the FDA”s website here.
What Parents Can Do
If you have the affected product, don’t use it. Return it to the place of purchase or dispose of it responsibly. Never leave medication in an open trash can. This poses a safety to risk to your child, wildlife/pets and other people. Direct questions or concerns to Tris Customer Service at 732-940-0358, Monday through Friday, 8 a.m. through 5 p.m. Pacific.
Parents who have concerns about their children’s health should contact their pediatrician or other qualified healthcare provider immediately.
Featured photo: Colin Maynard via Unsplash