The U.S. Food and Drug Administration has announced an infant ibuprofen recall. Tris Pharma issued a voluntary recall of its Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. Representatives from Tris Pharma referred to its statement online about the recall when reached for comment. With cold and flu season upon us, definitely check your medicine cabinets ASAP.

The infant ibuprofen, sold by CVS, Family Dollar and Walmart, may contain higher concentrations of ibuprofen than stated, 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 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.

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Parents who have concerns about their children’s health should contact their pediatrician or other qualified healthcare provider immediately.

—Erica Loop

Featured photo: Colin Maynard via Unsplash

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