Infant Ibuprofen Recall Issued Due To Overdose Risk

Several lots of infant ibuprofen are being recalled from Walmart, CVS, and Family Dollar stores nationwide, due to concerns that they could have higher concentrations of the active drug than the labels indicate, placing children at risk of an ibubrofen overdose. 

The FDA announced the Tris Pharma infant Ibuprofen recall on December 5, indicating that certain lots of the drug may contain higher potency levels than intended, leaving infants vulnerable to kidney injuries and other side effects associated with use of the drug at doses that are too high.

The recalled infant ibuprofen is an over-the-counter (OTC) liquid medication, which is designed to be used as a pain reliever and fever reducer, specifically for infants between the ages of 6 months and 23 months.

The announcement came after the manufacturer determined certain lots may have concentrations of ibuprofen that are too high and could result in overdosing to dangerous levels. Infants receiving the over-concentrated medications could suffer from nonsteroidal anti-inflammatory drug (NSAID) associated renal injuries, nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache, and gastrointestinal bleeding.

The products were manufactured by Tris Pharma, Inc. of Monmouth Junction, New Jersey. They were distributed to Wal-Mart, CVS, and Family Dollar stores nationwide.

The recall includes Equate Infant’s Ibuprofen Concentrated Oral Suspension sold in 0.5 ounce bottles with NDC number 49035-125.23 and Lot numbers 00717009A. 00717015A, and 00717024A. These bottles were sold at Wal-Mart stores with expirations dates of February 2019, April 2019 and August 2019.

Recalled CVS products include CVS Health Infant’s Ibuprofen Concentrated Oral Suspension sold in 0.5 ounce bottles with NDC number 59779-925-23 and Lot number 00717024A. The products were sold at CVS Pharmacies with expiration dates of August 2019.

Recalled Family Dollar Services products include Family Wellness Infants Ibuprofen Concentrated Oral Suspension sold in 0.5 ounce bottles with NDC number 55319-250-23 and Lot number 00717024A. The products were sold at Family Dollar stores nationwide and are marked with an expiration date of August 2019.

Tris Pharma has begun notifying its wholesalers and retailers of the recall and is directing them to remove the products from stores shelves. Customers with recalled bottles of Ibuprofen should stop using them immediately and contact Tris Customer Service at 732-940-0358 or email them at micc_tris@vigilarebp.com for information on how to return or discard the products.