FDA Expands Recall of Infant Ibuprofen Sold at CVS, Walgreens & More Stores


Trending Now


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.

—Erica Loop

Featured photo: Colin Maynard via Unsplash



Which Chicken Nuggets Have Been Recalled? There Are 3 Active Recalls Right Now

General Mills Recalls Gold Medal Flour Nationwide for Salmonella Risk

Recall Alert: Whole Foods Recalls Prepared Foods Made with Spinach

Welcome to our Tinybeans family!
Be sure to check your email for new activities, recipes and parenting hacks – and to see if you’ve won!








Enter to Win a $250 Gift Card!

Enter your email and zip code below for a chance to win a Mastercard Gift Card. We’ll pick one winner per month through October 31, 2022 – 7 lucky winners in all!

I agree to the official rules and to receive email communications from Tinybeans. By providing my email address, I agree to the Privacy Policy and Terms of Service.