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Generic Infant Ibuprofen Recalled From Stores: What Parents Need to Know

Certain brands of painkillers made for small babies have been recalled from CVS, Family Dollar, and Walmart. Here's what to know.

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There are a lot of reasons parents need to give their very young children over-the-counter painkillers. From teething pain to high fevers, when kids are under two-years-old, you’ve pretty much only got two options: Acetaminophen (commonly known as Tylenol) and Ibuprofen (the active ingredient in Motrin and Advil.) And right now, if you’ve purchased any Acetaminophen, including generic brands, you’re in the clear. But, if you’ve bought off-brand baby Ibuprofen recently, you may want to check the label. Here’s what’s going on.

UPDATE: On January 29, Tris Pharma expanded their previous recall to three additional lots manufactured for Walmart and CVS, meaning more infant ibuprofen sold at these stores could contain a higher concentration of ibuprofen than what is on the label. “Infants’ Ibuprofen Concentrated Oral Suspension”, the recalled product, was labeled to contain 50 mg. of ibuprofen per 1.25 mL.

According to a released statement from Tris Pharma, two of the newly recalled lots, Lot 4718, which was sold in a .5 oz. bottle with an expiration date of Dec. 2019, and lot 00717006A, which was sold in a 1 oz. bottle with an expiration date of Feb. 2019, were both manufactured under the “CVS Health” label. The third, Lot 00717005A, was sold in a 1 oz. bottle with an expiration date of Feb. 2019 and was manufactured under the “Equate” label at Walmart. Tris Pharma says it has not received any reports of serious problems occurring due to the recall and provided further explanation in its released statement on Tuesday.

“The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches,” The statement reads. “Safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.”

On December 5, 2018, Tris Pharma recalled three lots of infant Ibuprofen. These are the generic varieties sold at Walmart, CVS and Family Dollar, usually right next to the children’s Motrin. Basically, Tri Pharma is concerned these lots of the drug contained higher than normal concentration of Ibuprofen, which could harm some children. At this time, there have been no reported negative effects, but the symptoms to look for are nausea, vomiting, and diarrhea.

Still, because of the concern of the higher concentrations, any bottle or box containing these lot numbers have been recalled. So, if you have any generic baby Ibuprofen, take a look at the bottle and see if any of these lot numbers are on there. If parents want to be extra safe, just throw away any of these generic brands and replace them with any brand of Acetaminophen or actual Motrin. What follows is a chart with all the lot numbers and product descriptions.

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NDC LOT EXPIRATION DESCRIPTION COMPANY
49035-125-23 00717009A

00717015A

00717024A

02/19

04/19

08/19

Equate: Infants’

Ibuprofen

Concentrated Oral

Suspension,

USP (NSAID), 50

mg per 1.25 mL,

0.5 oz. bottle

Wal-Mart

Stores Inc

59779-925-23 00717024A 08/19 CVS Health:

Infants’ Ibuprofen

Concentrated Oral

Suspension,

USP (NSAID), 50

mg per 1.25 mL,

0.5 oz. bottle

CVS

Pharmacy

55319-250-23 00717024A 08/19 Family Wellness:

Infants’ Ibuprofen

Concentrated Oral

Suspension,

USP (NSAID), 50

mg per 1.25 mL,

0.5 oz. bottle

Tris Pharma has also issued this official statement:

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00 am ET- 5:00 pm PT) or via email at Customer Service Email. (ProductComplaints@trispharma.com) Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Basically, the company has set-up a process by which you can return to the product, but most parents will be in the clear if they either throw this stuff out or stop giving it to their kid.